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Role of Analytical Sciences in Drug Development and Commercialization

Outline of presentation. Key CMC challenges in drug developmentAnalytical challenges to facilitate drug developmentIncorporating Quality-bydesign concept in analytical method designAnalytical methodologies to characterize drug substance and drug productAnalytical methodologies to characterize t

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Role of Analytical Sciences in Drug Development and Commercialization

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    1. Role of Analytical Sciences in Drug Development and Commercialization Dilip R Choudhury, Ph. D. Allergan, Inc.

    2. Outline of presentation Key CMC challenges in drug development Analytical challenges to facilitate drug development Incorporating Quality-by–design concept in analytical method design Analytical methodologies to characterize drug substance and drug product Analytical methodologies to characterize the process Ensuring long term analytical method performance Conclusions 2

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