title: Regulatory perspective of bioanalysis from a clinical pharmacology reviewer standpoint: do you see what I see?
abstract: Clinical pharmacology plays an important role in drug development, including the evaluation of the drug's pharmacokinetics, pharmacodynamics, drug-interaction potential, exposure-response relationship and safety considerations when being used in specific populations. Clinical pharmacology data is pivotal in ensuring the delivery of the right drug, in the right dose, at the right time, to each particular patient and it has significantly influenced the risk/benefit assessment and labeling recommendations. Consequently, the reliability of the bioanalytical methods and data are of considerable importance, and the solid footing in drug development. Documentation of bioanalytical data from method validation or clinical trials is a critical element supporting regulatory submissions such as new drug applications or biologics license applications. Case examples are presented to highlight the utility and importance of bioanalysis in drug development to ensure that drug products are safe, efficacious, and given at the right dose.
authors.affiliation: Division of Clinical Pharmacology 3, Office of Clinical Pharmacology, Office of Translational Sciences, Center of Drug Evaluation & Research, US FDA, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
authors.forename: Chongwoo
authors.initials: C
authors.lastname: Yu
authors.forename: Edward
authors.initials: E
authors.lastname: Bashaw
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000592:standards; D059788:Dried Blood Spot Testing; D017277:Drug Approval; D033161:Government Regulation; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000378:metabolism / Q000592:standards; D011786:Quality Control; D011863:Radioimmunoassay / Q000592:standards; D053719:Tandem Mass Spectrometry / Q000592:standards; D013739:Testosterone / Q000032:analysis / Q000493:pharmacokinetics / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations; D013739:Testosterone