The application of population pharmacokinetic analysis to large scale clinical efficacy trials |
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| Authors: | Edward J. Antal Thaddeus H. GraselaJr. Randall B. Smith |
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| Affiliation: | (1) Clinical Pharmacokinetics Unit, The Upjohn Company, Kalamazoo, Michigan;(2) Departments of Pharmacy and Social and Preventive Medicine Schools of Pharmacy and Medicine, State University of New York, Buffalo, New York;(3) Harris Laboratories, Inc., Lincoln, Nebraska |
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| Abstract: | ![]()
Summary Results have been presented that demonstrate the ability to conduct population pharmacokinetic analysis as a component of clinical efficacy and safety trials. This method of analysis offers the potential to determine the pharmacokinetics of a drug in the actual patients receiving medication and to evaluate relationships between pharmacokinetics and drug action. However, active involvement in the protocol design, and data collection process are required to ensure the quality of the resultant data set. |
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