Physicochemical Characterization And Dissolution Study
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HPLC METHOD DEVELOPMENT -A REVIEW
www.gyanvihar.org1. Understand the physicochemical properties of drug molecule Physicochemical properties of a drug molecule play an important role in method development. For Method development one has to study the physical properties like solubility, polarity, pKa and pH of the drug molecule. Polarity is a physical property of a compound. It helps an analyst,
1. APPLICATIONS FOR INVESTIGATIONAL NEW DRUGS …
cdsco.gov.in14.2 Study report(s) as given in Appendix II 15 Therapeutic confirmatory trials (Phase III) 15.1 Summary 15.2 Individual study reports with listing of sites and Investigators. 16 Special Studies 16.1 Summary 16.2 Bio-availability / Bio-equivalence 16.3 Other studies e.g. geriatrics, paediatrics, pregnant, or nursing women.
Annex 7 - WHO
www.who.intAnnex 7 133 10.3.3 Dissolution profile comparison for biowaivers based on dose- proportionality of formulations 177 10.4 In vitro equivalence testing for non-oral dosage forms 177 10.5 In vitro equivalence testing for scale-up and post-approval changes 180 References 180 Appendix 1 Recommendations for conducting and assessing comparative