Design of clinical pharmacology trials

Duffull, SB (2001) Design of clinical pharmacology trials. Clinical And Experimental Pharmacology And Physiology, 28 11: 905-912. doi:10.1046/j.1440-1681.2001.03546.x


Author Duffull, SB
Title Design of clinical pharmacology trials
Journal name Clinical And Experimental Pharmacology And Physiology   Check publisher's open access policy
ISSN 0305-1870
Publication date 2001
Sub-type Article (original research)
DOI 10.1046/j.1440-1681.2001.03546.x
Volume 28
Issue 11
Start page 905
End page 912
Total pages 8
Editor Y. Yamori
J.Sassard
G. Fink
Place of publication Melbourne
Publisher Blackwell Science
Collection year 2001
Language eng
Subject C1
230204 Applied Statistics
730199 Clinical health not specific to particular organs, diseases and conditions
Abstract 1. There are a variety of methods that could be used to increase the efficiency of the design of experiments. However, it is only recently that such methods have been considered in the design of clinical pharmacology trials. 2. Two such methods, termed data-dependent (e.g. simulation) and data-independent (e.g. analytical evaluation of the information in a particular design), are becoming increasingly used as efficient methods for designing clinical trials. These two design methods have tended to be viewed as competitive, although a complementary role in design is proposed here. 3. The impetus for the use of these two methods has been the need for a more fully integrated approach to the drug development process that specifically allows for sequential development (i.e. where the results of early phase studies influence later-phase studies). 4. The present article briefly presents the background and theory that underpins both the data-dependent and -independent methods with the use of illustrative examples from the literature. In addition, the potential advantages and disadvantages of each method are discussed.
Keyword Pharmacology & Pharmacy
Physiology
Cross-over Design
Monte Carlo Simulation
Optimal Design
Pharmacokinetics
Population Analysis
Optimal Sampling Times
Cross-over Trials
Population Pharmacokinetics
Drug Development
Regulatory Perspective
Parameter-estimation
Healthy-volunteers
Simulation-model
Ivabradine
Implementation
Q-Index Code C1

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 5 times in Thomson Reuters Web of Science Article | Citations
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Created: Tue, 14 Aug 2007, 15:50:51 EST