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Sharan Murugan
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Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
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Sharan Murugan
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The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...
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Sharan Murugan
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...
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Sharan Murugan
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(o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
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Sharan Murugan
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...
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Sharan Murugan
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...
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