Excipient Variability and its Implications with Respect to Drug Quality from a Regulators perspective
Posted on December 19, 2024
Steven Wolfgang, Consumer Safety Officer, (Previously Chemist), FDA
Introduction Excipient variability has become a very timely topic for scientific discussion among suppliers and users of excipients and pharmaceutical scientists2. An eye opening finding from a recent survey conducted by the Product Quality Research Institute (PQRI) on excipient variability was the ...
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