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From time to time, the Food and Drug Administration (FDA) offers a lot of updates to its materials and practices, and any person involved with the industry needs to stay alert for new releases, educational events, and training.
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s recommendations...
China Pharma Holdings, Inc., a specialty pharmaceutical company, today announced that its Candesartan hypertension product passed key bioequivalence tests. The Company plans to use the results of the key benchmark tests of consistency evaluation to ...