title: The use of concentration measurements of parent drug and metabolites during clinical trials.
abstract: The need for well-designed pharmacokinetic (PK) and pharmacodynamic (PD) studies early in the development of new drugs is described. In this review we illustrate the application and cost-effectiveness of optimal sampling theory in PK study design for ongoing clinical trial studies of ethyol, a chemoprotector drug. The importance of careful selection of the appropriate biological fluid in which to measure drug concentration at the earliest possible stage of new drug development is described in the context of the development of new immunosuppressive drugs. We focus on the requirement for well-validated analytical methodology in PK-PD studies, described in a discussion of the analytical methodology in use in clinical trials of two immunosuppressive agents, cyclosporin G and RS-61443 (mycophenolate mofetil).
authors.affiliation: Department of Pathology and Laboratory Medicine, University of Pennsylvania Medical Center, Philadelphia.
authors.forename: L M
authors.initials: LM
authors.lastname: Shaw
authors.forename: H S
authors.initials: HS
authors.lastname: Bonner
authors.forename: L
authors.initials: L
authors.lastname: Fields
authors.forename: R
authors.initials: R
authors.lastname: Lieberman
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics; D003362:Cost-Benefit Analysis; D016903:Drug Monitoring / Q000191:economics / Q000379:methods*; D006801:Humans; D007166:Immunosuppressive Agents / Q000493:pharmacokinetics / Q000494:pharmacology; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010601:Pharmacology, Clinical; D012107:Research Design
chemical_list: D007166:Immunosuppressive Agents; D004364:Pharmaceutical Preparations