Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource
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Population Pharmacokinetics and Pharmacodynamics: An Underutilized Resource Susan E. Tett, Nicholas H. G. Holford and Andrew J. McLachlan Drug Information Journal 1998 32: 693 DOI: 10.1177/009286159803200310 The online version of this article can be found at: http://dij.sagepub.com/content/32/3/693
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0092-8615/98 Copyright Q 1998 Drug Information Association Inc.
Drug Information Journal, Vol. 32. pp. 693-710. 1998 Printed in the USA. All rights resewed.
POPULATION PHARMACOKINETICS AND PHARMACODYNAMICS: AN UNDERUTILIZED RESOURCE SUSANE. TE-IT,PHD, BPHARM(HONS) School of Pharmacy, University of Queensland, Brisbane, Australia
NICHOLAS H. G . HOLFORD,MSc, MBCHB, FRACP Department of Pharmacology & Clinical Pharmacology, University of Auckland. New Zealand
ANDREWJ. MCLACHLAN,PHD, BPHARM(HONS) Department of Pharmacy, University of Sydney, Australia
A meeting was convened in Canberra, Australia, at the request of the Australian Drug Evaluation Committee (ADEC), on December 3 4 , 1997 to discuss the role of population pharmacokinetics and pharmacodynumics in drug evaluation and development. The ADEC was particularly concerned about registration of drugs in the pediatric age group. The population approach could be used more often than is currently the case in pharmacokinetic and pharmacodynamic studies to provide valuable information for the safe and effective use of drugs in neonates, infants, and children. The meeting ultimately broadened to include discussion about other subgroups. The main conclusions of the meeting were: 1. The population approach, pharmacokinetic and pharmacodynamic analysis, is a valuable tool both for drug registration purposes and for optimal dosing of drugs in specific groups of patients, 2. Population pharmacokinetic andpharmacodynamic studies are able to 311 in the gaps’ in registration of drugs, for example, to provide information on optimal pediatric dosing. Such studies provide a basis for enhancing product information to improve rational prescribing, 3. Expertise is required to perform the population studies and expertise, with a clinical perspective, is also required to evaluate such studies if they are to be submitted as part of a drug registration dossier. Such expertise is available in the Australasian region and is increasing. Centers of excellence with the appropriate expertise to advise and assist should be encouraged to develop and grow in the region, 4. The use of the population approach by the pharmaceutical industry needs to be e
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