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Presented by S. Shanti Kumar PA-Ph.D-2012-103 1 2 3 4 Introduction Regulatory Aspects Implementation of QbD Proposals of EFPIA/PhRMA Paper 5 6 7 QbD- Analytical methods Benefits…

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Philip J. Koerner, Ph.D. Thailand September 2013 General Principles General Principles of HPLC Method of HPLC Method DevelopmentDevelopment Part 1. General Chromatographic…