Population pharmacokinetics and pharmacodynamics: An underutilized resource

Tett, S. E., Holford, N. H. and McLachlan, A. J. (1998) Population pharmacokinetics and pharmacodynamics: An underutilized resource. Drug Information Journal, 32 3: 693-710.


Author Tett, S. E.
Holford, N. H.
McLachlan, A. J.
Title Population pharmacokinetics and pharmacodynamics: An underutilized resource
Journal name Drug Information Journal   Check publisher's open access policy
ISSN 0092-8615
Publication date 1998-01-01
Year available 1998
Sub-type Article (original research)
Open Access Status Not yet assessed
Volume 32
Issue 3
Start page 693
End page 710
Total pages 18
Place of publication New York
Publisher Pergamon
Language eng
Subject 320500 Pharmacology and Pharmaceutical Sciences
321200 Public Health and Health Services
Abstract 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 pharmacodynamics 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 and pharmacodynamic studies are able to fill 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 encouraged to provide valuable information not obtainable by other techniques. The acceptance of population pharmacokinetic and pharmacodynamic analyses by regulatory agencies also needs to be encouraged, and 5. Development of the population approach to pharmacokinetics and pharmacodynamics is needed from a public health perspective to ensure that all available information is collected and used to improve the way drugs are used. This important endeavor needs funding and support at the local and international levels.
Keyword Health Care Sciences & Services
Pharmacology & Pharmacy
Population Pharmacokinetics
Pharmacodynamics
Pediatric Drug Use
Rational Drug Dosing
Pharmacostatistics
Clinical Drug Development
Pediatric-patients
Hiv-infection
Models
Performance
Fluconazole
Experience
Caffeine
Tacrine
Disease
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Pharmacy Publications
 
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Citation counts: TR Web of Science Citation Count  Cited 25 times in Thomson Reuters Web of Science Article | Citations
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Created: Mon, 13 Aug 2007, 20:43:47 EST