PMID: 11336357May 5, 2001Paper

Optimal design of a population pharmacodynamic experiment for ivabradine

Pharmaceutical Research
Stephen DuffullL Aarons

Abstract

To design a parsimonious population pharmacodynamic experiment that has the same or greater efficiency than that provided by two phase I studies. The design was based on optimization of the population Fisher information matrix. Options for optimization were (1) determination of the optimal sampling times for each group ("group" represents a group of subjects that have identical design characteristics), (2) determination of the optimal doses for each group, and (3) determination of the optimal group structure. (1) Optimizing the sampling times, while retaining only four unique times per group, provided a more parsimonious experiment with the same efficiency as the original "study" that involved on average 10 samples per subject. Splitting sampling times between the first dose and a steady-state dose gave the most informative design. (2) The optimal dose was the same in all groups and was the upper bound of the dose range. (3) The optimal population design consisted of only one group with four unique sampling times that are the same for all subjects. A population pharmacodynamic trial design is presented that is more parsimonious than the original study and would be appropriate for inclusion in a premarketing clinical study.

Citations

Sep 4, 2007·British Journal of Clinical Pharmacology·Goonaseelan Pillai, Jean-Louis Steimer
Aug 14, 2008·British Journal of Clinical Pharmacology·Juliana F RoosStephen B Duffull
Nov 15, 2005·Journal of Pharmacokinetics and Pharmacodynamics·Stephen DuffullJohn Eccleston
Apr 6, 2006·The AAPS Journal·Andrew Hooker, Paolo Vicini
Mar 14, 2008·Clinical Pharmacokinetics·Michel TodGérard Pons
Dec 13, 2005·Journal of Pharmacokinetics and Pharmacodynamics·Marylore ChenelLeon Aarons
Mar 26, 2009·Journal of Pharmacokinetics and Pharmacodynamics·Joakim NybergAndrew C Hooker
Mar 26, 2010·Clinical Pharmacology and Therapeutics·S ZamunerA C Hooker
Dec 30, 2011·Journal of Biopharmaceutical Statistics·Stephen B DuffullJohn Eccleston
Mar 11, 2009·Clinical Pharmacokinetics·Cornelia B LandersdorferFritz Sörgel
Jan 28, 2010·Basic & Clinical Pharmacology & Toxicology·Leon Aarons, Kayode Ogungbenro
Aug 15, 2013·Journal of Pharmacokinetics and Pharmacodynamics·C Steven ErnestAndrew C Hooker
Oct 6, 2005·Journal of Pharmacokinetics and Pharmacodynamics·Michael G DoddsPaolo Vicini
Nov 13, 2001·Clinical and Experimental Pharmacology & Physiology·S B Duffull
Jan 8, 2009·Journal of Biopharmaceutical Statistics·Kayode Ogungbenro, Leon Aarons
Nov 1, 2006·British Journal of Clinical Pharmacology·Stefanie HennigStephen B Duffull
Feb 28, 2009·Journal of Clinical Pharmacology·Stefanie HennigMats O Karlsson
Nov 15, 2008·Pharmaceutical Statistics·Kayode OgungbenroLeon Aarons

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