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According to the ICH guidance, the objective of method validation is to demonstrate that analytical procedures are suitable for their intended purpose Therefore the method s purpose should be linked to the clinical studies and the pharmaceutical purpose of the product being studied The purpose in the early phase of drug development is to deliver a known dose that is bioavailable for clinical studies As product development continues, increasing emphasis is placed on identifying a stable, robust formulation from which multiple, bioequivalent lots can be manufactured and ultimately scaled up, transferred, and controlled for commercial manufacture The development and validation of analytical methods should follow a similar progression The purpose of analytical methods in early stages of development is to ensure potency, to understand the impurity and degradation product pro le, and to help understand key drug characteristics.

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Figure 7.35 Throughput vs. CIR for EGPRS (all MCS) with incremental redundancy and with/ without frequency hopping (FH) and GPRS (CS1-2 and CS1-4).

Figure 25-9: Adding a GREP to the Preference settings for GoLive s Find feature. As the name reflects, this one removes all font tags, both opening and closing.

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1 G Bell and J Gray What s next in high-performance computing Commun ACM, 45(2):91 95, 2002 2 F Bertrand, R Bramley, A Sussman, D E Bernholdt, J A Kohl, JW Larson, and K Damevski Data redistribution and remote method invocation in parallel component architectures In Proceedings of the 19th International Parallel and Distributed Processing Symposium (IPDPS), 2005 (Best Paper Award) 3 K Damevski Parallel component interaction with an interface de nition language compiler Master s thesis, University of Utah, 2003 4 K Damevski and S Parker Imprecise exceptions in distributed parallel components In Proceedings of 10th International Euro-Par Conference (Euro-Par 2004 Parallel Processing), Vol 3149, Lecture Notes in Computer Science Springer, 2004 5 K Damevski and S Parker M N data redistribution through parallel remote method invocation Int J High Perform Comput Appl, 19(4):389 398, 2005 (Special issue) 6 JD de St Germain, J McCorquodale, S.

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11 The gross domestic product of a country is the sum of goods and services produced in the country or, in this instance, in the whole world. 12 Growth on Earth is presently driven by the nite reserves of fossil energy and materials. As such, growth cannot be sustainable in the long run; strictly speaking the term sustainable growth is a misnomer.

G Parker, and CR Johnson Uintah: a massively parallel problem solving environment In Proceedings of the 9th IEEE International Symposium on High Performance and Distributed Computing, August 2000 7 Enterprise Java Beans http://javasuncom/products/ejb, 2007 8 I Foster, C Kesselman, and S Tuecke The Nexus approach to integrating multithreading and communication J Parallel Distrib Comput, 37:70 82, 1996 9 S Gribble, E Brewer, J Hellerstein, and D Culler Scalable, distributed data structures for Internet service construction In Proceedings of the Symposium on Operating Systems Design and Implementation, 2000 10 A Gupta, B Liskov, and R Rodrigues One hop lookups for peer-to-peer overlays In 9th Workshop on Hot Topics in Operating Systems (HotOS-IX), Lihue, Hawaii, 2003, pp 7 12 11 C Johnson and S Parker The SCIRun parallel scienti c compouting problem solving environment.

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As development continues, the method should be stability indicating and capable of measuring the effect of key manufacturing parameters to ensure consistency of the drug substance and drug product Analytical methods used to determine purity and potency of an experimental API that is very early in development will need a less rigorous method validation exercise than would be required for a quality control laboratory method at the manufacturing site An early phase project may have only a limited number of lots to be tested and the testing may be performed in only one laboratory by a limited number of analysts The ability of the laboratory to control the method and its use is relatively high, particularly if laboratory leadership is clear in its expectations for the performance of the work.

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