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The Usefulness of Pharmacokinetics in the Development of Antineoplastic and Anti-Aids Agents

  • Julie L. Eiseman
Part of the NATO ASI Series book series (NSSA, volume 221)

Abstract

There are many difficulties to be faced, both ethical and scientific, in the introduction of a new agent into clinical practice. In the development of cytotoxic agents such as antineoplastic drugs and antiviral agents directed against HIV (human immunodeficiency virus) the path is similar. Clinicians deliver and patients take experimental treatments with the hope of therapeutic benefit in the face of a life threatening illness. In most cases, the chance of therapeutic benefit from the experimental treatment is low; in 187 clinical trials on 54 experimental agents the response rate was only 4% [Estey et al., 1986]. Since the likelihood of toxicity is much greater, investigators involved in the development of these cytotoxic agents must plan their experiments well and gain the most amount of information regarding the efficacy and toxicity of the agent with the fewest number of patients. It is the goal of this chapter to illustrate the successful use of pharmacokinetics in the development of two such therapeutic agents which have recently been introduced to the clinic as approved therapies: Carboplatin as an antineoplastic agent and Zidovudine as an anti-AIDS agent. Through these examples, the importance of pharmacokinetics during the Phase I testing of cytotoxic agents will be established and the use of pharmacokinetics in the development of these two agents will provide guidelines for future phase I testing strategies.

Keywords

Human Immunodeficiency Virus Antineoplastic Agent Total Body Clearance Antineoplastic Drug Total Platinum 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Plenum Press, New York 1991

Authors and Affiliations

  • Julie L. Eiseman
    • 1
    • 2
  1. 1.Division of Developmental TherapeuticsUniversity of Maryland Cancer CenterBaltimoreUSA
  2. 2.Department of PathologyUniversity of Maryland School of MedicineBaltimoreUSA

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