Dublin, April 07, 2025 (GLOBE NEWSWIRE) -- The "Bioavailability and Bioequivalence Studies submitted in NDAs and INDs" training has been added to ResearchAndMarkets.com's offering. Attendees that need ...
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) ...
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on ...
The draft guidance provides recommendations for data integrity for clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted with drug applications. On April 1, 2024, ...
NEW DELHI: Coming down hard on Semler Research Center over data integrity issues, USFDA has told drug firms that their applications seeking approvals on the basis of studies done by the ...
New York, United States , Sept. 05, 2023 (GLOBE NEWSWIRE) -- The Global Bioequivalence Studies Market Size is to grow from USD 661.4 million in 2022 to USD 1451.7 million by 2032, at a Compound Annual ...
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