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Generic = Branded Drug, What are the Facts? Krebs Qin
July 03, 2024
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.
Updates on the Bioequivalence Studies for Drugs Submitted to Under an ANDA Lin Zhang
April 08, 2022
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.
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA FDA
February 18, 2022
In August 2021, FDA revised the draft guidance for industry on Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to update and clarify the agency’s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's Candesartan Hypertension Product Passes Bioequivalence Tests and the Company Plans to Apply for NMPA Approval prnasia
August 05, 2021
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 ...
FDA releases guidance on bioavailability and bioequivalence study samples europeanpharmaceuticalreview
August 21, 2020
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.