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The clinical laboratory in pharmaceutical development
1Department of Laboratory Medicine, Children's National Medical Center, Washington, D.C. 20010, USA.
Therapeutic Drug Monitoring
|April 1, 1995
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.