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The application of population pharmacokinetic analysis to large scale clinical efficacy trials

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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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References

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Author information

Authors and Affiliations

  1. Clinical Pharmacokinetics Unit, The Upjohn Company, Kalamazoo, Michigan

    Edward J. Antal Ph.D.

  2. Departments of Pharmacy and Social and Preventive Medicine Schools of Pharmacy and Medicine, State University of New York, Buffalo, New York

    Thaddeus H. Grasela Jr. Pharm.D.

  3. Harris Laboratories, Inc., Lincoln, Nebraska

    Randall B. Smith Ph.D.

Authors
  1. Edward J. Antal Ph.D.
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  2. Thaddeus H. Grasela Jr. Pharm.D.
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  3. Randall B. Smith Ph.D.
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Antal, E.J., Grasela, T.H. & Smith, R.B. The application of population pharmacokinetic analysis to large scale clinical efficacy trials. Journal of Pharmacokinetics and Biopharmaceutics 19 (Suppl 3), S37–S46 (1991). https://doi.org/10.1007/BF01371007

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  • DOI: https://doi.org/10.1007/BF01371007

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