Transcription of Reflection paper on the dissolution specification …
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Reflection paper on the dissolution specification …
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 13 May 2016 1 EMA/332805/2016 2 Committee for Medicinal Products for Human use (CHMP) 3 Committee for Medicinal Products for Veterinary use (CVMP) 4 Quality Working Party (QWP) 5 Reflection paper on the dissolution specification for 6 generic oral immediate release products 7 Draft 8 Draft agreed by the QWP March 2016 Draft adopted by the CHMP for release for consultation March 2016 Draft adopted by the CVMP for release for consultation April 2016 St
considered: 80 • Selection of a suitable dissolution medium should be based on the physico- chemical characteristics 81 of the active substance(s) and the intended dose range of the drug pr oduct to be tested.
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