Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. Republication of Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability, WHO Technical Report Series, No. 992, Annex 7 with a New Appendix 2. WHO Technical Report Series, No. 1003, 2017, Annex 6
(2017; 56 pages)

Abstract

Following the publication of the Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability in 2015, it was noted that a text on equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients (APIs) according to the Biopharmaceutics Classification System (BCS) would be a useful addition. The method for determination of equilibrium solubility was suggested to be added as an appendix to the above-mentioned guidelines.

 
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