- Sep 25
- 2 min
Malaysia’s NPRA: Guidance for Bioequivalence Inspection
- Apr 4
- 2 min
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
- Mar 27
- 2 min
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
- Apr 29, 2023
- 1 min
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
- Feb 1, 2023
- 1 min
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
- Feb 1, 2023
- 1 min
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- Dec 2, 2022
- 1 min
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
- Apr 24, 2022
- 1 min
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
- Aug 21, 2021
- 1 min
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA