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Apr 42 min read

USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Mar 272 min read

USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...

Feb 1, 20231 min read

Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies

Recently (30 January 2023) Health Canada updated their guidance document on "Conduct and Analysis of Comparative Bioavailability...

Dec 2, 20221 min read

USFDA Guidance: Statistical Approaches to Establishing Bioequivalence

Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...

Apr 24, 20221 min read

Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines

Finished Product Labeling and Packaging Guidelines To provide guidance on how to make sure the information on labels and package leaflets...

Apr 17, 20222 min read

FDA's Bioavailability Guidance for NDAs or INDs- General consideration

The US Food and Drug Administration (FDA) has published a final guidance regarding bioavailability data that drug sponsors should include...