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WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms
Short Title:
TRS 1044 - Annex 11
Origin/Publisher:
WHO headquarters, Avenue Appia 20, 1211 Geneva 27, Switzerland Telephone: (+ 41 22) 791 21 11, Facsimile (fax): (+ 41 22) 791 3111, Telex: 415 416, Telegraph: UNISANTE GENEVA
Content:
The aim of the WHO Biowaiver List is to enable an informed decision as to whether or not a waiver from in vivo bioequivalence studies could be granted safely according to the WHO guidance Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
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