Biomaterial Database

The clinical laboratory in pharmaceutical development. 1995

K C Gunter, and R C Rock

Department of Laboratory Medicine, Children's National Medical Center, Washington, D.C. 20010, USA.

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.

UI	MeSH Term	Description	Entries
D002626	Chemistry, Pharmaceutical	Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.	Medicinal Chemistry,Chemistry, Pharmaceutic,Pharmaceutic Chemistry,Pharmaceutical Chemistry,Chemistry, Medicinal
D002984	Clinical Laboratory Information Systems	Information systems, usually computer-assisted, designed to store, manipulate, and retrieve information for planning, organizing, directing, and controlling administrative and clinical activities associated with the provision and utilization of clinical laboratory services.	Laboratory Information Systems,Information Systems, Clinical Laboratory,Information System, Laboratory,Information Systems, Laboratory,Laboratory Information System,System, Laboratory Information,Systems, Laboratory Information
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016903	Drug Monitoring	The process of observing, recording, or detecting the effects of a chemical substance administered to an individual therapeutically or diagnostically.	Monitoring, Drug,Therapeutic Drug Monitoring,Drug Monitoring, Therapeutic,Monitoring, Therapeutic Drug