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WHO Protocol to conduct equilibrium solubility experiments for the purpose of Biopharmaceutics Classification System-based classification of active pharmaceutical ingredients for biowaiver

Short Title:
TRS 1019 - Annex 4
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 objective of this document is to provide guidance on the design and conduct of equilibrium solubility studies undertaken for the purpose of active pharmaceutical ingredient (API) classification within the Biopharmaceutics Classification System (BCS) (1, 2)

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