USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Malaysia’s NPRA: Guidance for Bioequivalence Inspection
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA