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WHO Multisource (generic) pharmaceutical products: guidelines on registration requirements
Short Title:
Annex 6, WHO Technical Report Series 1003
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
Document Type:
Guideline
Content:
The guidance provides appropriate in vivo and in vitro requirements to assure interchangeability of the multisource product without compromising the safety, quality and efficacy of the pharmaceutical product.
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