Discriminatory dissolution method development
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dx.doi.org/10.14227/DT190412P36 Development …
www.dissolutiontech.com36 Dissolution Technologies | NOVEMBER 2012 Development and Validation of a Dissolution Method for Pioglitazone Tablets A. P. Kulkarni*, Mohd Shahnawaz, Zahid Zaheer, and M. H. G. Dehghan
Reflection paper on the dissolution specification …
www.ema.europa.euperformance. 97 However, in all cases the dissolution profiles at increased stirring speeds should have sufficient 98 discriminatory power for drug product quality control .
Developing a Discriminating Dissolution …
www.dissolutiontech.comDissolution Technologies| FEBRUARY 2004 13 Developing a Discriminating Dissolution Procedure for a Dual Active Pharmaceutical Product with Unique Solubility Characteristics ...
Reflection paper on the dissolution specification for ...
www.ema.europa.euThis 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
Regulatory Expectations of Presentation of …
www.ukpharmsci.orgSafeguarding public health Regulatory Expectations of Presentation of Dissolution Data David Darling Pharmaceutical Assessor Medicines and Healthcare products
In Vitro Dissolution Testing for Solid Oral Dosage …
www.particlesciences.comthe USP recommended ionic strength.5 For APIs that exhibit low solubilities in aqueous me-dia throughout the pH range, the addition of surfactants is recom-mended.
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