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WHO Propasal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate release, solid oral dosage forms
Short Title:
Annex 8, WHO Technical Report Series 937
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, www.who.int
Content:
This paper aims to give national authorities sufficient background information on the various orally administered active pharmaceutical ingredients (APIs) on the WHO Model List of Essential Medicines (EML), also taking into account local usage of the API, to enable them to make an informed decision as to whether generic formulations should be subjected to in vivo bioequivalence (BE) studies or whether a biowaiver can be granted.
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