Regulated Bioanalysis for Small Molecules - Bioanalysis 2020

Diaa Shakleya, CDER Office of Pharmaceutical Quality (OPQ), discusses Bioanalytical Method Validation (BMV) and data quality. He presents case studies on in vivo evaluation of pediatric products of Oseltamivir (Tamiflu) and Brompheniramine in a pre-clinical pig model, bioavailability evaluation and pharmacokinetic assessment of novel galantamine formulations, and determination of systemic exposure level of dexamethasone in rabbit following implantation of the sustained release intravitreal implant drug product.
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