Discriminatory dissolution method developmentFound 6 free book(s)
36 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
performance. 97 However, in all cases the dissolution profiles at increased stirring speeds should have sufficient 98 discriminatory power for drug product quality control .
Dissolution Technologies| FEBRUARY 2004 13 Developing a Discriminating Dissolution Procedure for a Dual Active Pharmaceutical Product with Unique Solubility Characteristics ...
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
Safeguarding public health Regulatory Expectations of Presentation of Dissolution Data David Darling Pharmaceutical Assessor Medicines and Healthcare products
the 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.
14227/DT190412P36 Development, Dissolution, Development, Dissolution Method, Paper on the dissolution specification, Discriminatory, Developing a Discriminating Dissolution, Developing a Discriminating Dissolution Procedure for, Regulatory Expectations of Presentation of, Regulatory Expectations of Presentation of Dissolution