Transcription of Reflection paper on the dissolution specification for ...
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Reflection paper on the dissolution specification for ...
10 August 2017. EMA/CHMP/CVMP/QWP/336031/2017. Committee for Medicinal Products for Human use (CHMP). Committee for Medicinal Products for Veterinary use (CVMP). Quality Working Party (QWP). Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action 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.
This reflection paper does not discuss the dissolution tests in three different buffers required as complementary to bioequivalence studies , those tests required in support of biowaiver of strengths or
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