TRS 1044 - Annex 11: WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Annex 11, WHO Technical Report Series 1044, 2022
31 March 2022
| Technical document
Overview
The World Health Organization (WHO) recognizes the possibility of waiving in vivo bioequivalence studies for immediate-release, solid oral dosage forms with active pharmaceutical ingredients (APIs) belonging to classes I and III according to the Biopharmaceutical Classification System (BCS), using comparative dissolution studies as surrogate proof of bioequivalence (1).
WHO Team
Access to Medicines and Health Products (MHP),
Health Product Policy and Standards (HPS),
Norms and Standards for Pharmaceuticals (NSP),
Technical Standards and Specifications (TSS)