title: The clinical laboratory in pharmaceutical development.
abstract: The clinical laboratory plays an important part in the development of new pharmaceutical agents. The nature of this role will vary depending on the stage of clinical development of the drug and the goals of a particular investigation. Therefore, it may be appropriate to conduct and interpret clinical trial laboratory tests differently from the standard methods used in routine clinical analysis. The training and background of laboratory directors are important in providing both prospective and on-site management of laboratory testing during pharmaceutical clinical trials.
authors.affiliation: Department of Laboratory Medicine, Children's National Medical Center, Washington, D.C. 20010, USA.
authors.forename: K C
authors.initials: KC
authors.lastname: Gunter
authors.forename: R C
authors.initials: RC
authors.lastname: Rock
mesh_terms: D002626:Chemistry, Pharmaceutical; D002984:Clinical Laboratory Information Systems; D002986:Clinical Trials as Topic / Q000592:standards; D016903:Drug Monitoring; D006801:Humans