Articles by Wendy Mavroudakis - Pharmaceutical Technology

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Articles by Wendy Mavroudakis

Wendy Mavroudakis


Industry Takes Steps Toward Greener API Manufacturing
November 2, 2005

This article provides a PhRMA perspective and recommendations on an FDA guidance currently under development dealing with postapproval changes after the final intermediate of the active pharmaceutical ingredient, i.e., BACPAC II. The concept of a "last true solution" is proposed as an additional point in the assessment of potential risk associated with process changes.

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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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