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1. U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidance for industry: Changes to an approved NDA or ANDA, available: http://www.fda.gov/cder/guidance/3516fnl.pdf, accessed Apr. 15, 2006. 2. European Commission, Guideline on dossier requirements for type IA and type IB noti cations: Pharmaceuticals: Regulatory framework and market authorizations, available: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/gdvartypiab_rev0_ 200307.pdf, accessed Apr. 20, 2006. 3. Department of Health and Ageing, Therapeutic Goods Administration, Australian regulatory guidelines for prescription medicines. Appendix 12: Changes to the quality information of registered medicines: Noti cation. Self-assessment and prior approval, available: http://www.tga.gov.au/pmeds/argpmap12.pdf, accessed Apr. 12, 2006. 4. Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidance for industry: SUPAC-IR: Immediate-release solid oral dosage forms: Scale-up and post-approval changes: Chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, available: http://www.fda.gov/cder/ guidance/cmc5.pdf, accessed May 11, 2006. 5. Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidance for industry: Comparability protocols Chemistry, manufacturing, and controls information (draft), available: http://www.fda.gov/cder/guidance/5427dft.pdf, accessed Apr. 15, 2006. 6. Brazilian Sanitary Surveillance Agency (ANVISA), Resolution: Guide for making postregistration alterations, inclusions and noti cations of drug products, Brazil s generic drug policy, industry legislation, available: http://www.anvisa.gov.br/hotsite/genericos/legis/ resolucoes/893_03re_e.htm, accessed Apr. 11, 2006. 7. U.S. Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Guidance for industry: SUPAC-MR: Modi ed release solid oral dosage forms scale-up and postapproval changes: Chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioequivalence documentation, available: http://www.fda.gov/cder/guidance/1214fnl.pdf, accessed May 5, 2006.

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A benchmark is a standard of measurement. A computer benchmark is a set of programs that performs work or operations on a system and returns back the capability of the tested configuration. It defines the speed and throughput of the system. Speed is how fast the system can complete a predetermined set of activities. Throughput is the amount of workload that can be done per unit time. The advantage of a benchmark is that it allows us to run the same set of operations (or workload) on different configurations, thereby providing a comparison. Since no two applications are the same, it would be ideal to test different configurations with your own applications to compare them. But, that is very difficult in the real world because of lack of expertise, time, money, feasibility, and other constraints.

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Miscellaneous cGMP deviations (other than below) Failed USP dissolution test requirements Microbial contamination of non-sterile products Lack of efficacy Impurities/degradation products Lack of assurance of sterility Lack of product stability Labeling: Label error on declared strength Misbranded: Promotional literature with unapproved therapeutic claims Labeling: Correctly labeled product in incorrect carton or package

Although CIECAM97s is a fairly simply model it is also quite complete in the variety of phenomena predicted. It includes correlates of all the important appearance dimensions (lightness, brightness, chroma, colorfulness, saturation, and hue) and it can predict a wide range of adaptation-, surround-, and luminance-dependent effects. It is not applicable to extremely high or low luminance levels, which are atypical of careful color judgements. Example calculations using the CIECAM97s color appearance model as described in this chapter are given for four samples in Table 15.2. A spreadsheet with these example calculations can be found at <www.cis.rit.edu/fairchild/ CAM.html>.

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