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 Start of public consultation 13 May 2016 End of consultation (deadline for comments) 13 August 2016 9 Comments should be provided using this template. The completed comments form should be sent to 10 Keywords dissolution specification , Generic, Oral immediate release product 11 12 Reflection paper on the dissolution specification for generic oral immediate release products EMA/332805/2016 Page 2/9 Reflection paper on the dissolution specification for 13 generic oral immediate release products 14 Table of contents 15 Introduction.
performance. 97 However, in all cases the dissolution profiles at increased stirring speeds should have sufficient 98 discriminatory power for drug product quality control .
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