Analytical Test Methods in Downstream Processing

Analytical Test Methods in Downstream Processing Andrea Waldvogel Validation of Analytical Test Methods in Downstream Processing Introduction Quality, safety and efficacy are the main principles of quality assurance of biopharmaceutical drug products. Quality must be designed into the product or process since it cannot be tested into it. Therefore, a quality system must comprise of validation, change control, training, quality control and vendor assurance amongst others.1-3 An effective validation does not only provide a high degree of confidence that the finished drug product consistently and reliably meets all quality requirements but also leads to economic benefits by reducing the cost associated with process monitoring, sampling and testing.4 Biopharmaceutical companies must perform facility, utility and equipment validation/qualification, process validation, computer and computer systems validation, cleaning validation and analytical method validation.5 This project report will focus on analytical method validation, also referred to as analytical procedure validation. Analytical methods are developed to measure characteristics such as molecular identity, purity, potency, and safety of raw materials, in-process samples and final drug products and to monitor the manufacturing process. The number of tests should be adequate to show manufacturing consistency and the impact of changes on the quality of the drug product. All methods must be demonstrated to be fit for their intended purpose before they are employed.5,6 Analytical method validation means establishing documented evidence that provides high degree of assurance that a specific method, and the ancillary instruments included in the method, will consistently yield results that accurately reflect the quality characteristics of the product tested.7 This report begins by providing an overview over some of the regulations and guidelines related to analytical method validation. The second section introduces the modern lifecycle approach to method validation and section three gives an insight into analytical method validation in biopharmaceutical downstream processing. The final section concludes the report with a summary of the main points discussed. There are many different regulations, guidelines and pharmacopeial monographs concerned with analytical method validation. As it would go beyond the scope of this document to write about all of them, the report focuses on some to give an overview. 1.1 Regulations Validation is based on, but not prescribed by regulatory requirement. It is best viewed as an essential and integral part of Good Manufacturing Practice (GMP) for the assurance of quality. Compliance with validation requirements is necessary for obtaining approval for clinical trials and to market new products.4 In the U.S. for example, 21 CFR Part 211.165(e) states8: The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with  § 211.194(a)(2). 21 CFR Part 211.194(a) (2)8: A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (à ¢Ã¢â€š ¬Ã‚ ¦). The suitability of all testing methods used shall be verified under actual conditions of use. The requirement of validation is also implied in 211.100(a)8: There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 1.2 Guidelines The first guidance documents on analytical method validation were published in the 1990s. In the course of time, a lot of revision activity has taken place allowing the incorporation of new approaches to science. The harmonised ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology guideline, issued in 2005, is considered the primary reference for recommendations and definitions on validation characteristics for analytical procedures and has tended to take on the role of a regulatory expectation. In the United States, it has been used as a guidance along with the related compendial documents USP Analytical Procedure Validation, Analytical Procedure Verification, and Analytical Procedure Transfer. However, those documents do not provide support for the users to accurately understand and control sources of variability.6,9 In 2013, a Stimuli to the Revision Process paper on Lifecycle Management of Analytical Procedures published by the USP Validation and Verification Expert Panel proposed a Quality by Design (QbD) approach to method development, validation, and performance verification of an analytical method via a lifecycle concept. They suggested that the traditional approaches outlined in the U.S. Pharmacopeial monographs , , and should be revised and assembled into a single new general information chapter Lifecycle Management of Analytical Procedures and a new general chapter specifying the basic requirements. This would, for the first time, formally link method development and method validation within pharmacopeia.6,10 In 2016, a general chapter prospectus on The Analytical Procedure Lifecycle was posted on the U.S. Pharmacopeial Notices and a draft of a new USP General Chapter Statistical Tools for Procedure Validation was published in the U.S. Pharmacopeial Forum (U.S. Pharmacopeial Convention).11,12 In August 2017, a new general USP Chapter Validation of Compendial Methods will become official. This is an effort to better align the validation concept with the revised FDA guidance for industry Analytical Procedures and Methods Validation for Drugs and Biologics issued in 2015. However, instead of including a section on Lifecycle Management of Analytical Procedures only a reference has been added. Depending on the development of the chapters and , USP may be revised again.13 Growing awareness that the implementation of an analytical method with adequate quality steps designed into the procedure during the development phase led to the development of a lifecycle approach for analytical procedure validation.10 2.1 Stages of the Modern Lifecycle Approach The modern lifecycle approach is based on the Quality by Design (QbD) approach outlined in ICH Q8(R2) guideline and defines activities and deliverables for every stage of method validation. The following diagram provides an overview. Figure 1: QbD Approach for Analytical Methods 2.1.1 Stage 1: Procedure Design, Development, and Understanding To be able to design quality into a method to ensure that the method is reliable and meets the analytical target profile (ATP) defined at the beginning of this stage, an understanding of how the procedure works is key. Risk assessment should be undertaken to identify variables that could have an influence on the method. The knowledge of variables and their impact is not only important for the development of a control strategy but also for the determination of a design space. The design space will reduce the amount of revalidation work considerably when the method is used operationally. Key elements of this stage are shown in Figure 1 no. 1-3.10 Proper method development including the evaluation of robustness is essential for an effective analytical procedure.10 Robustness is a measure of the methods capacity to remain unaffected by small variations in method parameters and provides an indication of its reliability during normal usage.9 At this stage, system suitability parameters are established which help to ensure that the analytical method remains valid whenever used.9 Without developing a robust method and an understanding of how a change of key parameters will impact its performance, the actual method validation step will be difficult.10 2.1.2 Stage 2: Procedure Performance Qualification The lifecycle approach uses the term procedure performance qualification instead of method validation. Procedure performance qualification is the verification of the performance of the analytical procedure (either a new one or a revised procedure) against the requirements of the ATP.10 If the procedure development has been done correctly, this step should simply be a confirmation that it is fit for the intended purpose. In cases where further controls need to be added to ensure reliable results the analytical control strategy, developed during stage 1, will need an update.10 Method validation work should be performed by a user laboratory under the same conditions as it will be used to comply with existing GMP regulations.10 2.1.3 Stage 3: Implementation and Continued Procedure Performance Verification This stage involves checking how the procedure works during operational use and that it remains in a state of control.10 For this purpose, inputs on reliability and performance of the method gathered from operators and customer complaints will be evaluated. Performance indicators such as system suitability, quality control samples and out-of-specification (OOS) results are tracked and trended.10 The method should be continually improved through corrective and preventive action to reduce the number of out-of-specification (OOS) results. Any change to improve the overall performance needs to be assessed using change control procedures. As shown in Figure 3, the nature of the change specifies what actions have to be taken.6,10,14 Figure 2: Change Types and appropriate Actions 2.2 Traditional (Current) Approach vs Lifecycle Approach In their Stimuli to Revision paper, the USP Expert Panel recommends the adoption of a lifecycle approach for the management of analytical procedures. In their conclusion, they outline the advantages of a lifecycle approach by comparing it to the traditional (current) approach to analytical procedure validation (Figure 1).6 Downstream processing in biopharmaceutical manufacturing involves many steps from recovery over purification to fill finish. Next to in-process monitoring of process parameters such as pH and temperature, analytical testing for the determination of quantity, identity, strength, potency, purity (product- and process related impurities), bioburden and endotoxin has to be performed on raw materials, intermediates, drug substances and finished drug products. Some of the analytical methods in downstream processing are HPLC, gel electrophoresis, PCR, ELISA, Bradford, hemagglutination (HA) and plaque assay. All critical steps in a process have to be validated and less critical steps have to be under control. The criticality of an analytical method is determined by risk assessment. There are various ways to perform method validation. The manufacturer is responsible for choosing the suitable validation procedure and justifying it.1,7,9 3.1 Types of Analytical Procedures The four most common types of analytical procedures are identification tests, qualitative and quantitative tests for impurities and assay. Assay involves the quantitative measurement of the major component(s) in the drug substance and drug product.9 3.2 Team Selection The validation project manager is responsible for the selection of a Cross-Functional-Team (CFT) from various related departments and functional areas. He or she is also in charge of assigning responsibilities and assuring that all personnel involved are trained properly.7 3.3 Analytical Method Validation Protocol The first step in method validation is the preparation of a protocol that defines the work to be done to demonstrate that the method is fit for its intended use.7,10 The analytical method validation protocol should contain the following sections: Purpose Short description of what is to be accomplished Scope of the project specifying the test methods and products Overview General description of the test method Summary of the characterisation studies Identification of method type and validation approach Test method applications and validation protocol Intended use of each test method application Analytical performance characteristics for each test method application Resources End user laboratory where the method validation is to be performed Equipment and materials to be used in the method validation Special instructions on handling, stability, and storage for each material Appendices References, signature, and a review worksheet for all personnel Specific tasks for all personnel and documentation of their training Listings of all equipment and software necessary to perform the method validation Document and materials worksheets used in method validation Test method procedures (SOPs) Before the method validation can begin the protocol must be agreed upon by the CFT and approved.7 3.4 Performance Characteristics Tests Performance characteristics and their acceptance criteria are defined during the characterisation studies at the development stage of the analytical method. Depending on the method and its intended use, some performance characteristics tests may be omitted, the number of replicates may be increased or reduced, or acceptance criteria may be adapted. All decisions have to be based on scientifically sound judgment. It is important that well characterised reference materials, with documented purity, are used for testing performance characteristics.7,9 The following table outlines the performance characteristics and their meaning, test procedures, how data should be reported and acceptance criteria according to ICH Q2(R1) and FDA Guidance for Industry on Analytical Procedures and Method Validation. Accuracy Closeness of test results to the true value For drug substances, accuracy measurements are obtained by comparing test results to the analysis of a standard reference material or to a second, well-characterized method. For drug products, accuracy is evaluated by analysing synthetic mixtures (containing all excipient materials in the correct proportions) spiked with known quantities of analyte. Guidelines recommend that data be collected from a minimum of nine determinations over at least three concentration levels covering the specified range. The data should be reported as the percent recovery of the known, added amount, or as the difference between the mean and true value with confidence intervals (such as  ±1 SD). Acceptability criteria are defined by end users but rarely fall outside 97-103% of the nominal value. Statistical analysis can be applied using a one sample t-test. Precision Degree of agreement among test results when the method is applied repeatedly to multiple samplings of a homogeneous sample Precision is commonly described in terms of repeatability, intermediate precision, and reproducibility: Repeatability is investigated by analysing a minimum of nine determinations using the same equipment and sample, covering the specified range of the procedure, or a minimum of six determinations at 100% of the test concentration and reported as percent relative standard deviation (RSD). Intermediate precision refers to the agreement among the results from a single laboratory, despite potential variations in sample preparation, analysts, or equipment. Reproducibility refers to the agreement among the results from different laboratories. Results are reported as % RSD, and the percent difference in the mean values between the analysts must be within specifications. Less than 2% RSD is often recommended, but less than 5% RSD can be acceptable for minor components. Specifity Ability to measure accurately and specifically the analyte of interest in the presence of other components In drug assays, specificity takes into account the degree of interference from other active ingredients, excipients, impurities, degradation products, or matrices. In chromatography, it ensures that a chromatographic peak corresponds to a single component. Specificity can be demonstrated by the resolution between peaks of interest. Limit of detection (LOD) Lowest concentration of an analyte in a sample that can be detected In a chromatography laboratory, the most common way to determine both the LOD and the LOQ is using signal-to-noise ratios (S/N), commonly 3:1 for LOD and 10:1 for LOQ. An appropriate number of samples must be analyzed to fully validate the method performance at the limit. Limit of quantitation (LOQ) Lowest concentration of an analyte in a sample that can be quantified with acceptable precision and accuracy under the stated operational conditions of the method Linearity Ability of a method to provide results that are directly proportional to analyte concentration within a given range Guidelines specify that a minimum of five concentration levels be used to determine the range and linearity, along with certain minimum specified ranges depending on the type of method. The range is normally expressed in the same units as the test results obtained by the method (for example, nanograms per millilitre). Data to be reported generally include the equation for the calibration curve line, the coefficient of determination (r 2), residuals, and the curve itself. Range Interval between the upper and lower concentrations of an analyte that have been demonstrated to be determined with acceptable precision, accuracy, and linearity using the method Robustness Measure of a methods capacity to obtain comparable and acceptable results when perturbed by small but deliberate variations in procedural parameters It provides an indication of the methods suitability and reliability during normal use. During a robustness study, method parameters (such as eluent composition, gradient, and detector settings) are intentionally varied to study the effects on analytical results. Common chromatography parameters used to measure and document robustness include critical peak pair resolution (R s), plate number (N) or peak width in gradient elution, retention time (t R), tailing factor (T F), peak area (and height) and concentration. Robustness studies are expected to be done during method development. Table 7 gives an overview of the performance characteristic tests that have to be performed on different types of analytical procedures.9 Figure 6: Performance Characteristic tests performed on different Types of Analytical Procedures The performance characteristics are evaluated by comparing the results to the specifications defined at the development stage. An analytical method is considered to be validated when it meets the specifications defined at the development stage. Once an analytical method has been made a formal part of the manufacturing process, it is extremely difficult to remove it. In the event of changes in the drug substance, the composition of the finished product and in the analytical procedure, revalidation may be necessary.5,7,9 3.5 Validation Documentation Every validation step needs to be documented to be able to provide written evidence to the regulatory authorities that a specific method is fit for its purpose. Documentation associated with method validation are validation protocols, standard operating procedures (SOPs), specifications and validation reports. Downstream processing in biopharmaceutical manufacturing involves many analytical methods which help to ensure quality, safety and efficacy of the final drug product. Development, validation and control of a robust analytical method is a lengthy and difficult task. However, without written evidence that an analytical method is fit for its intended use the company will not obtain a marketing authorisation. Over time, many guidelines and pharmacopeial monographs have been issued and a lot of revision activity has happened especially following the Stimuli to Revision paper published in 2013. Even though, no comprehensive guideline or monograph incorporating the modern lifecycle approach has been issued yet. Although proper development of robust and effective analytical methods is more time-consuming and expensive, it has many advantages. It leads to more efficient validation, variability is reduced and controlled and analytical method-related out-of-specification results and failure investigation are minimised. Additionally, changing method parameters within the design space facilitates continual improvement as it does not require regulatory re-approval. Validation is a team effort. Members of the CFT need to be properly trained. Their first and most demanding task is the preparation of a protocol which defines the scope of the validation project and provides all details necessary for a successful validation. It also defines, depending on the type of the analytical procedure, which performance characteristics need to be tested. The use of well characterised reference materials with known purity is important. Analytical method validation is considered to be complete when all acceptance criteria are met and a validation report has been written.       Bibliography References 1 Choudhary, A. (2009). Validation in Pharmaceutical Manufacturing. Pharmaceutical Guideline. [Accessed on 1 March 2017]. Available on Internet: http://www.pharmaguideline.com/2010/12/validation.html 2 International Conference on Harmonization (2009). Harmonised Tripartite Guideline: ICH Q8(R2) Pharmaceutical Development. [Accessed on 1 March 2017]. Available on Internet: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf 3 Stockbridge, P. (2008). Biopharmaceutical Fill and Finish: Technical and Operating Challenges for the Latest Formulations and Devices. BioProcess International. [Accessed on 7 March 2017]. Available on Internet: http://www.bioprocessintl.com/2008/biopharmaceutical-quality-assurance-184041/ 4 Nandhakumar, L.; Dharmamoorthy, G.; Rameshkumar, S.; Chandrasekaran, S. (2011). An Overview of Pharmaceutical Validation: Quality Assurance View Point. IJRPC, 1(4). [Accessed on 1 March 2017]. Available on Internet: http://www.caidat.org/m4atomp3/2561456335400862.pdf 5 Lutz, H. (2005). Introduction to Validation of Biopharmaceuticals. BioPharm International. [Accessed on 1 March 2017]. Available on Internet: http://www.biopharminternational.com/introduction-validation-biopharmaceuticals 6 USP Validation and Verification Expert Panel (2013). Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. Stimuli to the Revision Process Article. [Accessed on 1 March 2017]. Available on Internet: https://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/revisions/lifecycle_pdf.pdf 7 Shabir, G. A. (2004). Step-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry. IVT Network: Analytical Method Validation, pp. 4-14. [Accessed on 2 March 2017]. Available on Internet: http://www.ivtnetwork.com/sites/default/files/Analytical%20Method%20Validation.pdf 8 U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Parts 211.165(e), 211.194(a) and 211.100(a). [Accessed on 2 March 2017]. Available on Internet: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=211 9 International Conference on Harmonization (2005). Harmonised Tripartite Guideline: ICH Q2(R1) Validation of Analytical Procedures, Text and Methodology. [Accessed on 1 March 2017]. Available on Internet: http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html 10 McDowall, R. D. (2014). GLP and GMP Approaches to Method Validation Going the same Way?. Spectroscopy, 29(4). [Accessed on 1 March 2017]. Available on Internet: http://www.spectroscopyonline.com/glp-and-gmp-approaches-method-validation-going-same-way 11 U.S. Pharmacopeial Convention (2016). General Chapter Prospectus: The Analytical Procedure Lifecycle. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/notices/1220-analytical-procedure-lifecycle 12 U.S. Pharmacopeial Convention (2014). New USP requirements for Analytical Method Validation. USP-NF, Notices. [Accessed on 2 March 2017]. Available on Internet: http://www.usp.org/usp-nf/pharmacopeial-forum 13 ECA Academy (2017). Revised USP Chapter Validation of Compendial Methods approved. [Accessed on 2 March 2017]. Available on Internet: http://www.gmp-compliance.org/gmp-news/revised-usp-chapter-1225-validation-of-compendial-methods-approved 14 Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/flyers/Public/Recent_regulatory_updates_and_trends_in_analytical_method_validation.pdf Illustrations Figure 1: Huber, L. (2015). Recent Updates and Trends in Analytical Method Validation. PPP of The Agilent Critical Compliance Seminar. [Accessed on 7 March 2017]. Available on Internet: http://www.agilent.com/cs/library/fl

Sartre’s Criticisms on Human Essence in the Light of Aristotle’s Philosophy

Our ability to engage in abstraction is, indubitably, a unique gift endowed to our human cognition. And the reason for such a telling contention is near to being self-evident: i. e. , only human persons have the ability to see through otherwise distinct and separate entities, a unifying concept that reveals these things’ common nature, if not their defining essence. To this end, it is necessary to point that our human intellect’s preponderance to abstracting the essences is another facet of human cognition. This is because knowing, akin to seeing, affords us an immediate grasp of reality’s nature and purpose; for by the mere experience of something, say a table, we almost instantly furnish ourselves with a working concept about the thing’s essence – i. e. , we ‘know’ what a table is, what is it for. Thus, it makes sense to say that abstracting essences form part and parcel of both the intuitive and inductive process of a person’s ability to know reality. Our understanding of the concept of essence draws chiefly from the scheme provided by the Greek metaphysics. And herein it would insightful to take cue from Aristotle’s ‘hylemorphic’ framework. According to Aristotle, anything that exists – say, a tree or a dog – is constituted of both an existence and an essence; i. e. , all things both have material and formal constitutions. On the one hand, existence pertains to the act of being, or the facticity of a thing. For example, that table is being actual right when one sees it. On the other hand, essence pertains to the nature of a certain thing. It is that which makes a thing to be what it is; an abstracted concept which makes us see the connection between the entities that we are perceiving (say, a table) and the other things (say, a classroom filled with tables) belonging to the same genre or species (Lavine 71). Essence thus defines the nature of a certain thing or describes the aspect proper to the same. If we proceed with this line of argumentation, we can go on to claim that one can apply the concept of essence to pertain to reality of human persons. From here, we can move to identify conspicuous aspects which may be deemed ‘proper to human persons’, so as to glean what we may call â€Å"human essence† – i. e. , that a person is an existing being, that he shows characteristic elements proper to animals, but that he possess a faculty of intellect and freewill proper to him and him alone. In the ultimate analysis, one can say that the essence defining a human person lies in framing him as a living creature that shares certain characteristic traits of animals, but is endowed nevertheless with the unique faculty of intellect and freewill. Key to this process, it must be argued, is describing the determinate aspects of his very existence. To be sure, we may still identify a good number of characteristic elements that could equally describe what it means to be human person. And surely, we cannot stop at construing fundamental animality and rationality as aspects that sufficiently capture the â€Å"whatness† of humanity; for the reasoned construction of human essences does not entail that we have completely circumscribed the total reality of human persons. That having said, Jean Paul Sartre believes that humanity has no fixed essence. In other words, he believes that humanity cannot be framed within the parameters of determinateness or the limits we impose by construing human essences. At the very least, Sartre contends that we cannot define the contours of what it means to be a person because our freedom determines the unique manner of our very existence. J. Sartre’s contention fundamentally draws from his concept of absolute human freedom. A thinker who belongs to the erstwhile group of philosophers known as Existentialists, Sartre’s philosophy puts higher premium than most on appreciating human existence as a concrete and perpetual striving for one’s own becoming (Marias 436). This means that, for Sartre, we as human persons must constantly appreciate the fact we exist, more than the fact that we have an essence to frame our subsequent courses of actions. Sartre believes that â€Å"we are necessarily free†, and that the burden of â€Å"making† our own human essence lies in the choices that we make (Marias 440). Put in layman’s terms, Sartre believes that our freedom is absolute, and that, even more importantly, the choices we make determine the kind of person that we are. In a way, Sartre reverses the logic of human essence – i. e. , human actions does not flow from one’s own essence; instead, human essence is molded by the actions that we as persons commit to doing. For such reason, and as mentioned earlier, Sartre believes that humanity has no fixed essence. And insofar as the concrete form of our human essence takes cue only from the activities which human persons do, Sartre rests his case on the plain assumption that one’s life cannot be placed within any restricting concepts of essence, for any reason whatsoever (Marias 440-441). There are reasons to think, however, that Sartre may have framed human freedom quite radically and that his wholesale denial of an identifiable human essence may have been taken quite drastically. To this end, strains of Aristotle’s philosophy may be helpful in shedding light into some of the oversights Sartre may have committed in denying the tenability of human essence on account of absolute freedom. Firstly, it may be insightful to be reminded of the fact that Aristotle understands human essence as an aspect of life that does not effectively restrict human capacity to determine one’s path according to the sets of actions a person may willingly opt for. Human essence merely speaks of the kind or quality of existence which is construable from and identifiable in a certain thing (Lavine 71). It merely serves to help man appreciate what kind of creature he is by way of categories and definitions. Conversely, the concept of human essence does not, in any whatsoever, imply an absolute determination of human reality according to these set of classification or categorization. An example may help further situate the conundrum: when someone thinks of man as essentially a spiritual being – i. e. , the capacity for spiritual relations with God belongs properly to the characteristic trait of humanity – one does not rule out the possibility of not believing in God all together. Instead, one merely makes a statement about the humanity’s general preponderance to worshipping a deity, notwithstanding personal choice to dissent. The same goes true for human essence. Sartre thinks that humanity has not a fixed essence on account of a human freedom that determines a resulting human nature. Unfortunately for Sartre, human essence and human freedom are not mutually exclusive. In fact, a person’s freedom is only affirmed, if not accentuated by the fact that the human essence is defined by a tacit acknowledgement of man’s of basic rationality and capacity for freewill. Secondly, Sartre’s contention that human persons have no fixed essence is certainly difficult to argue precisely because human freedom is really not absolute and that humanity’s basic essence does not depend on human choice but on what nature has fundamentally given. Two aspects come into play with in this particular rebuttal. In the first place, Sartre may have taken human freedom quite radically in arguing that it our capacity to determine ourselves must be taken in absolute terms – i. e. , we can do whatever we wish; besides, we are the ones determining our resulting essence in the process. This, unfortunately, is untenable. For instance, if I, born as a human person, were to choose living like a dog, I would probably find certain dog-like activities incongruent with my natural bodily processes. I would find it difficult to bark, let alone walk in a four-legged manner; as these are not consistent with how was I born and raised. The point in contention here lies in arguing that human freedom, contrary to Sartre’s arguments, cannot be taken as an absolute determinant of human nature. On the contrary one may find it difficult to deliberately deviate from the demands of our basic human essence. Such difficulty should bring us more into an appreciation of our human nature not really as an aspect dependent on human choice, but an aspect that is made perfect by the choices that we make. Herein Aristotle’s teleological philosophy appears to take shape. According to Aristotle, essence precedes actions, or essence precedes existence; and that the perfection of all actions comes when they fulfill the essence in question (Marias 74). For instance, when a person uses critical thinking before making a judgment, such an act can be considered as a perfection of the man’s nature as a rational entity. The point in contention here lies in arguing that we cannot really do away with human nature. On the contrary, our actions must run consistent with it; for only when we act according to our nature can our actions be perfected according to our essence. By way of conclusion, I wish to end with a thought that dismisses Sartre’s contention – i. . , that humanity cannot find a common essence proper to himself and himself alone – on account of its patent inability to take into account the true state of human affairs. In the discussions that were developed, it was learned that Sartre’s refutation of human essence stems from his belief that human freedom is absolute, and that human persons are the ones molding their respective essences. However, there are surely good reasons to think that this p hilosophical stances does not hold water. First, it has been argued that the concept of human essence does not in any way defeat the reality of human freedom. Human nature and human freedom, it was argued, are not mutually exclusive. Second, Sartre appears to have neglected the fact that human freedom cannot be equated with the capacity to do what one wishes, regardless of what nature has already given. There is no such thing as an absolute freedom. And in the final analysis, we have to admit that we are bound by a certain essence, no matter how hard try to deviate from it.

Native American Education Essay - 1530 Words

Native American Education Through the years minority groups have long endured repression, poverty, and discrimination. A prime example of such a group is the Native Americans. They had their own land and fundamental way of life stripped from them almost unceasingly for decades. Although they were the real â€Å"natives† of the land, they were driven off by the government and coerced to assimilate to the white man’s way. Unfortunately, the persecution of the Natives was primarily based on the prevalent greed for money and power. This past impeded the Native American’s preservation of their culture as many were obviated of the right to speak the native language and dress in traditional clothing. Because of this cultural expulsion, among other†¦show more content†¦They inculcated these Western values in the young American Indians in order to overcome their innate activities and ideals which prove to be quite distinct from those of Americans. Many Native Americans strongly believed t hat abuse of an infant would lead to the death of its soul or some physical abnormality, notes Driver, and so the Aztecs postponed harsh discipline until later years because of their belief in mild treatment of the youth. However, boarding schools disregarded this and severely beat and even killed some students as discipline. These policies at school clearly demonstrate how the native way of life was targeted. According to Barry Pritzker, those who attended the Indian boarding schools experienced attempts to destroy their native culture. They were taught that they were incapable of learning and succeeding. For them, with education came repression and violence. So because of these hapless experiences in boarding schools mainstream education is often frowned upon by them. The Native Indian history of violence and debasement changed their views and self-image as well. This change later affects how they adapt to American culture and education after being dissuaded from embracing their own for so long. The violence and indifference shown towards the Native Americans during the â€Å"Trail of Tears† contributed greatly to this change. In this dreadful journey, Natives of all kinds were forced offShow MoreRelatedThe Education Of Native Americans Essay1317 Words   |  6 Pagesaccomplishment compared to that of a college degree or getting a first job. Though it is just as important to have, it is seen as basic and necessary, with 82% of public education students graduating high school during the 2013-14 year (nces.ed.gov, 2016). However, for a variety of reasons, many students drop out of high school. Native American students have the lowest high school graduation rate of any non-White group in the U.S. Granted that reasons may vary from drug issues , work, family, or just disinterestRead MoreNative American Education Essay1368 Words   |  6 Pagesgroup is the Native Americans. They had their own land and basic way of life stripped from them almost constantly for decades. Although they were the actual â€Å"natives† of the land, they were forced by the government to give it up and compelled to assimilate to the white man’s way. This past scarred the Native American’s preservation of culture as many were discouraged to speak the native language and dress in traditional clothing. Because of this cultural neglect, among other things, Native Indians haveRead MoreEarly Education of Native Americans830 Words   |  3 PagesNative Americans put up a good fight in defending their homelands against foreign invaders. Unfortunately, they suffered defeat and realized they would have to adapt to a new way of life. The battle for their lands was over, but the battle for their identities would just begin. However, it w ould not be the hardened warriors engaging in this conflict. Instead, the young Native American children would witness first-hand the American government’s solution to the Indian problem. Boarding schools wereRead MoreNative American Education Essay907 Words   |  4 PagesThe modern American society is best defined by its education. The â€Å"American dream† is founded on going to school, getting a good job, and becoming successful. Ironically, the actual native peoples of this country are actually the least likely to attain this dream. The largest obstacle they face is lack of proper education. The standard educational practices being used for the instruction of Native American peoples is not effective. There are many pieces to this road-block, and many solutionsRead MoreNative American Education Essay2273 Words   |  10 Pagescivilize Native Americans. They sent children to these schools against their will. Native American children were educated like Americ ans and they had to change their native ways to be more like whites (Cayton 266). Teachers abused their students and beat their native ways out of them. They were not allowed to see their families so they would try to escape, but their attempts were unsuccessful. The United States government’s Boarding Schools of the mid-late 1800s irreparably changed Native American cultureRead MoreIssues with Native American Education Essay1528 Words   |  7 PagesEducation has been a topic of controversy for many years now, and will continue to be for years to come. The modern American society is best defined by its education. A good part of the average person’s life is spent at school, going to school, and paying for school. However, even though education is so obviously very important, there are many groups in America that are getting shorted. The Native Americans are a key group that has struggled the most. The largest obstacle they face is lack ofRead More Special Educati on Implementation For Native American Girls Essay1712 Words   |  7 PagesSpecial Education Implementation For Native American Girls Quality education for children has been an ongoing issue for todays society. There has also been an increasing concern for the education of students with special needs. The effect of these concerns has been noted in many communities, such as the Native American community. The population of special education students in the Native American communities is not necessarily higher than others, however, their community is effectedRead MoreMy People The Sioux And The Lives Of Native Americans Essay1627 Words   |  7 PagesStanding Bear’s account of his life growing up as a Sioux Native American amidst a nation flourishing with change is a powerful and poignant narrative that draws us deeper into the history of The United States. My People the Sioux and the life of Luther Standing Bear are both crucial in examining the positive connotations of Indian Boarding Schools and the use of education to challenge the inferiority complex surrounding Native Americans. Luther Standing Bear was born in December of 1868 and thisRead MoreLiberty And Education For All America, The Land Of Opportunity1531 Words   |  7 PagesLiberty and Education for All America, the land of opportunity. Many people imagine of making their dreams a reality in the country of the United States, some do succeed but for others it is out of their reach. Many people do not think of the fight for education to be an issue in America, especially since America is called â€Å"the best nation on Earth†. It is like when Malala from Pakistan fought for rights that everyone should have the right to education. Education is said to be the key to successRead MoreCultural Values Of Cultures, Navajo, Laguna, And Euro American Culture1003 Words   |  5 PagesThis essay will explore the cultural values of three different cultures; Navajo, Laguna, and Euro-American culture. Two of the cultures that I will be exploring are the Native communities that I have been well exposed to since I was a child. The values that I will be discussing are gender, education, and money. Growing up on a reservation in New Mexico, I have a closer insight on the similarities and diffe rences of those values. The first value I will be analyzing is gender. Gender is a topic that

Application of BI Technologies on Universities in General - Free Essay Example

Sample details Pages: 7 Words: 2205 Downloads: 4 Date added: 2017/06/26 Category Technology Essay Type Descriptive essay Did you like this example? A brief review of the application of BI technologies on universities in general. In today’s digital era, both for-profit and non-for-profit organisations operate within a dynamic, highly competitive and technologically turbulent environment. Consequently, the development of strategic agility and business velocity by utilizing the unprecedented breadth of information plays a catalytic role in organisations’ sustainability and prosperity. In organisations’ quest to cost-effectively and rapidly harness data, business intelligence technologies seem to be a propitious tool. Business Intelligence (BI) is defined as a set of technologies, processes and methods enabling users to gather, store, access and analyse data in order to convert it into meaningful and useful information that facilitates business decision making (Negash, 2004). Business Intelligence systems not only can manage all forms of quality data (Dell’Aquila et al., 2008) but they can also generate ready-to- use information at the right time, area and format which leads to time ly and more effective decision making and planning (Negash, 2004). Although the concept of BI is not widerspread (diadedomenh h xrhsh tou) for some industries, the term BI emerged fifty years ago (in 1958) by Hans Peter Luhn in an IBM article (Cebotarean, 2011). The most ubiquitous term of Business Intelligence is that suggested by Howard Dresner in 1989 who characterized BI as an â€Å"umbrella† concept as it encompasses all the decision making and information systems within all functions of an organization (Cebotarean, 2011). Business intelligence is the evolution of data warehousing, since what differentiates it from the latter is the fact that it provides users with tailored solutions adjusted to the specific business sector, business problems and needs (White, 1999). In corollary, BI technologies facilitate and accelerate access to all forms of up-to-date information and its dissemination among all departments for customised decision making, planning and problems solv ing by generating an accessible and flexible operating environment (White, 1999).What emerges from this is that BI application benefits the organization both through the development of competitive â€Å"intelligence† which gives a valuable insight of the competitive environment of the organization and as a managerial tool for effective management of the organization- either by enhancing its functionality in terms of cost-effectiveness and time-savings or by monitoring and optimizing its business units (Berta, 2012). Many industries have widely deployed BI technologies due to the plethora of advantages that provide. However, in education sector, the paucity of previous BI applications on Universities, the perceived less competition and managers’ perception that activities such as teaching are more essential for University’s well-function decelerated the adoption BI technologies by Universities (Piedade and Santos, 2010). Nowadays though, the wide breath of dai ly digitized data yielded at every educational activity (Selwyn 2014), the increased competition on the one hand and the decreased number of prospective students due to the increased tuition fees on the other as well as Universities’ funding requirements which accomplishment is depending on University’s data provided to government (HEFCE, 2013) and the high and varied expectations of all stakeholders such as students, alumni and lecturors have rendered BI imperative for Universities’ sustainability. This is reflected by the incremental adoption of data-driven approaches by Universities (Selwyn, 2014) not only for addressing internal issues in fields such as administration, admissions, library and operational resources management but also for attracting and retaining students through profiling and tracking and better understanding of their competencies to name some but a few (Piedade and Santos, 2010). One of the core applications of BI on Universities is thos e related to students. By conducting students’ surveys and leveraging daily data generated by students’ interaction with Universities’ platforms and facilities, Universities can gain a better insight of their own student marketplace and students’ needs and habits, monitor student achievements, evaluate their satisfaction and strengthen their relationship with alumni and current and potential students (Jisc, 2012). Therefore, not only can universities employ BI technologies to attract, satisfy and retain students (Weaver, 2013) through Student Relationship Management (SRM) but they can also improve students’ academic performance through customized offerings and in turn increase of satisfaction (Piedade and Santos, 2010). For instance, University of Maryland, Baltimore County (UMBC) has utilized BI technology in order to provide students with a platform that allow them anonymously to juxtapose their academic activities (Siemens and Long, 2011). Mo reover, as Admission office is probably the first contact of students with the University, it is critical to be well-informed, well-organised and available. The admissions personnel are responsible not only effectively and timely cope with students’ applications but it should also reply to any enquire and make recommendations to students as well as instill University’s culture in students. Consequently, admission offices should be able to store, access and deal with a wide array of data in order to keep in touch with applicants and disseminate the elicited information to other departments by leveraging advanced BI technologies. Along with the fact that the first applications of information management systems on Universities appeared for library and academic resource management purposes (Langlois, 1998), libraries are a cornerstone of every world-leading University (Weaver, 2013). Nowadays, with the widespread usage of digital libraries due to the constant access to a vast breadth of knowledge regardless of time and country boundaries, Universities are heavily invest in acquiring academic databases (Zhang, 2011). Therefore, a core challenge faced by University’s libraries is the aggregation of both digital and physical recourses and their integration into a unified platform in order to interrelate and detect users’ preferences and provide them with cutomised recommendations according to their field of research and cross-referencing articles and books (Zhang, 2011). The mobile application of Boston College University Libraries which provides both librarians and students with an interactive platform of reading lists recommendations according to the subject, information of the availability of study rooms and computer clusters is a representative example of BI applications(Logi Analytics, n.d.). Finally, librarians can track information resources scarcity and optimize the library classification system and improve library services by u tilizing data related to frequency of book loans, books condition and frequency and purpose of library usage (Zhang, 2011). Last but not least, BI technologies are employed by Universities for improving cost-effectively Campus buildings utilisation and Campus facilities (Jisc, 2012). By monitoring the usage of University’s buildings, electricity consumption and staff requirements, universities can optimize and detect superfluous operating expenses (Berta, 2012). Finally, through text mining, Universities can extend and tailor University’s accommodation and its facilities through students’ feedback to increase students’ satisfaction and identify patterns in order to suggest off-campus accommodation that meet students’ needs. In general, not only do BI technologies enhance students’ learning experience (Siemens and Long, 2011) through improvements in course context and learning methods (Langlois, 1998) , but they also provide Universitie s with useful KPIs illustrating University’s performance and areas for improvement (Berta, 2012) that could be utilized to increase University ranking and improve their competitive position (Selwyn 2014). It is also worth noting that the development of BI decrease the uncertainty of decision making for Universities (Selwyn, 2014) as well as for government as it generates tractable data that promote transparency (Eynon, 2013) and thus, contributes to raising funds (HEFCE, 2013) . A description of the organisation including the business area of interest and the available datasets (existing or possible to be obtained either internally or externally). The University of Manchester is one of the world’s leading research Universities envisioning to be amongst the top 25 research Universities worldwide till 2020 (Strategic Plan, n.d.). The University of Manchester is inextricably linked to the history of city of Manchester, as it constitutes a national heritage chronolog ised in 1824 (Strategic Plan, n.d.). In its status quo was formed in 2004 after the University of Manchester Institute of Science and Technology (UMIST) merged with the Victoria University of Manchester (UoM history, 2015). Its societal and scientific contribution is evident, as it counts of twenty-five Nobelist among them Rutherford who proved the â€Å"splitting of atom† (Strategic Plan, n.d.). Therefore, its academic reputation has spawned the interest of recruiters, rendering University of Manchester a point of reference for top-companies and leading to noticeable external funds raining (The University of Manchester, 2014). The University of Manchester is the largest single-site University in the United Kingdom possessing 339 campus buildings in Manchester (The University of Manchester, 2014, p.32). On top of that, it invests more than any other UK University in improving and expanding its facilities (Strategic Plan, n.d.). The University of Manchester structure is com prised by four faculties with the Faculty of Medical and Human Sciences accompanied the most Institutions and Schools (11 in number) (The University of Manchester, 2014, p.18). Moreover, its campus includes 23 accommodation buildings tailored according to students’ needs and preferences and provides students with approximately 8,500 rooms (The University of Manchester, 2014, p.12). It is worth noting that one of its top priorities is the environmental sustainability as its activities has a great impact on local community (Strategic Plan, n.d.). It is exceptional that the University of Manchester has the largest student community compared to other Universities in the UK with more than 265,000 alumni connected in 200 countries around the world (UoM Alumni, 2015) and 38,430 current students (The University of Manchester, 2014, p.12). Moreover, it provides the largest variety of degree programmes and therefore it employs more than 17,000 people (The University of Manchester, 2 014, p.12). In this line, it is evident the emphasis is given on people not only to preserve and instill the University of Manchester’s culture and heritage but also to ensure high quality services. Last but not least, the University of Manchester Library has a significant cultural heritage value as it has academic collections dating back five millennia as well as great contribution to the reputation of the University of Manchester (Library strategy, 2013).Moreover, it is â€Å"the largest non-legal deposit academic library† in the UK (manchester.ac.uk, 2015) and one of only five national research libraries (The University of Manchester Library, 2015).According to SCONUL’s research, the University’s Libraries have the second-highest number of users with the Main Library being the most popular among the users (LibQUAL, 2011) and one of the largest e-resources (SCONUL, 2012). In particular, the University has eleven Libraries in which four million books and printed academic resources are provided, notwithstanding the 450 thousand e-resources and hundreds of databases (Library strategy, 2013). In University’s quest to provide students and staff with efficient, extended and high-quality research and study experience, the University has launched The Alan Gilbert Learning Commons building in 2012, offering more than one thousand study spaces and hence expanding its IT accessible spaces to over three thousands (Strategic Plan, n.d.). Before this investment, the University Library had far below the average IT-enabled seats (284 units) compared to other research UK Universities (SCONUL, 2012, p.21) which was inadequate if we consider that it has approximately fifty thousand potential users including students and staff, spends more than any UK University and five times more than average spending on acquiring e-resources (SCONUL, 2012, p.58) and according to LibQUAL report 72% of University users visit libraries in order to access e-resources (LibQUAL, 2011) . However, the University’s emphasis on harmonizing the use of today’s highly-needed digital resources by heavily investing in information systems and technology with the use of physical resources by enhancing libraries, has not only rendered the University’s library as one of the most well-resourced libraries but it has also improve the quality of research and learning (Strategic Plan, n.d.). The University of Manchester Library plays a pivotal role not only in University’s reputation and performance (Tenopir et al., 2012), but also in students’ choice of University. According to Price et al. (2003), four of the first six determining criteria for students’ University choice are related to library facilities (Price et al. 2003). On top of that, there is a strong empirical evidence that the usage of libraries from students is positively related to students’ retention, performance and success (Emmons and Wilkinson, 2010; Wong and Webb, 2010; Stone and Ramsden, 2013). Furthermore, the Tenopir et al.’s research (2012) in which University of Manchester participated illustrates that sufficient library resources contribute to the recognition and reward of academic staff research (Tenopir et al., 2012). Finally, intriguing of new ideas and improvement of assignment is strongly attributed to adequacy and use of libraries for both University of Manchester students (Jubb et al., 2010) and academic staff (Tenopir et al., 2012) Driven by Library contribution and value, most of the University of Manchester departments collaborate in order to continuously improve and extend its provided Library facilities (Library strategy, 2013). For instance, it participates and develops several new projects aiming at enhancement of collaboration and customization, such as â€Å"StORe† project enabling the researchers to share data and relevant information and the project â€Å"Scarlet Augmen ted reality† (The University of Manchester Library, 2015) and facilitating the usage and access for both digital and physical resources (e.g the mobile application which interactively illustrates available computer clusters). Although, according to LibQUAL’s survey (2011) 94% of respondents were satisfied with Libraries’ facilities, 87% of respondents was satisfied with Main Library amenities, mainly due to issues pertaining to the physical environment of library and resources availability (LibQUAL, 2011). In this paper, we will articulate the functionality of library classification combined with computer clusters allocation by analyzing a synthetic dataset. However, it is a wide range of available datasets of past and up-to-date data, available internally by the University of Manchester Library and IT department as well as externally through Society of College, National and University Libraries (SCONUL), LibQUAL+ ®,Higher Education Statistics Agency (HESA) and JISC and its platforms such as MIMAS. Don’t waste time! Our writers will create an original "Application of BI Technologies on Universities in General" essay for you Create order