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
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
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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).