Articles by Bob Mehta - Pharmaceutical Technology

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Articles by Bob Mehta

Understanding ICH Q11—FDA's Guidance on the Development and Manufacture of Drug Substances

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.
May 2, 2013

The author provides a review of FDA's guidance document, Guidance for Industry: Q11 Development and Manufacture of Drug Substances, and its relation to the International Conference on Harmonization's Q11 document and its application to the industry.

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