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bioequivalence

Generic = Branded Drug, What are the Facts?

Generic BE bioequivalence

It is no secret that the U.S. military does not trust the quality of generic drugs, and their disagreements and disagreements with the FDA over the quality control of generic drugs have long been made public.

July 3, 2024 by Krebs Qin

Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA

FDA Bioequivalence Generic drug

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.

April 8, 2022 by Lin Zhang

Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

ANDA Bioequivalence FDA

In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s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...

February 18, 2022 by FDA

China Pharma's Candesartan Hypertension Product Passes Bioequivalence Tests and the Company Plans to Apply for NMPA Approval

NMPA bioequivalence hypertension Candesartan

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 ...

August 5, 2021 by prnasia

FDA releases guidance on bioavailability and bioequivalence study samples

FDA bioavailability bioequivalence

The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.

August 21, 2020 by europeanpharmaceuticalreview

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Pharma Sources Insight July 2025: GLOBAL APISOURCING TRENDS