Example: biology
Of in vivo bioequivalence requirements
Found 2 free book(s)ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …
asean.orgensure comparable in vivo performance, i.e. similarity in terms of safety and efficacy. In bioequivalence studies, the plasma concentration time curve is generally used to assess the rate and extent of absorption. Selected pharmacokinetic parameters and preset acceptance limits allow the final decision on
ASEAN GUIDELINE ON SUBMISSION OF MANUFACTURING …
www.hsa.gov.sgChanges: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (FDA, 1997) Dissolution Testing of Immediate Release Solid Oral Dosage Forms (FDA, 1997) 2. SCOPE This guidance document applies to the solid oral dosage formulations – capsules, tablets and powder /