Pharmaceutical Development For Multisource Generic Pharmaceutical
Found 3 free book(s)
WHO Expert Committee on Specifications The International ...
www.who.intGuidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities. WHO Technical Report Series 992 Forty-ninth report WHO Expert Committee on Specifications for Pharmaceutical
ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …
asean.org- Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to establish Interchangeability (WHO) - Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/ 192217/2009 The guideline should also be read in conjunction with relevant guidelines on pharmaceutical quality.
DEVELOPMENT OF PAEDIATRIC MEDICINES: POINTS TO …
www.who.intworking document qas/08.257/rev.3 august 2011 restricted development of paediatric medicines: points to consider in pharmaceutical development