Transcription of Concept paper on the development of product …
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Concept paper on the development of product …
25 July 2013. EMA/CHMP/423137/2013. Committee for Medicinal Products for Human Use (CHMP). Concept paper on the development of product - specific guidance on demonstration of bioequivalence Agreed by Pharmacokinetics Working Party July 2013. Adoption by CHMP for release for consultation 25 July 2013. Start of public consultation 01 August 2013. End of consultation (deadline for comments) 30 September 2013. Comments should be provided using this template. The completed comments form should be sent to Keywords Bioequivalence, generics 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416.
Concept paper on the development of product -specific guidance on demonstration of bioequivalence EMA/CHMP/423137/2013 Page 3/3 If required, a brief scientific rationale for the guidance will be provided.
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