PMID: 11336356May 5, 2001Paper

Design and power of a population pharmacokinetic study

Pharmaceutical Research
P I Lee

Abstract

This paper investigated the influence of critical design factors on the power of a population pharmacokinetic (PK) study for identifying subpopulations that have different drug clearance than the typical population. A study simulation approach was used for the power estimation. The design factors included the number of subjects, sampling scheme, and compliance. The false positive rates of incorrectly identifying a subpopulation were estimated for several scenarios. The false positive rates of the population PK study was relatively low, except when the numbers of subjects with full profiles and the subjects with troughs were distributed between populations in an unbalanced manner. The total number of subjects did not seem to have as much influence on study power as the number of subjects in the subpopulation, as long as the total number of subjects was significantly larger than the subpopulation. The variability of sampling time played an important role in both the statistical power and the accuracy of the estimated difference in clearance. Taking three samples provided greater power and better accuracy than taking two samples per subject. Taking only trough samples provided little power and poor estimation of clearance differen...Continue Reading

Citations

Aug 29, 2009·Pharmaceutical Statistics·Kayode Ogungbenro, Leon Aarons
Dec 14, 2011·Journal of Pharmacokinetics and Pharmacodynamics·Chakradhar V LagishettyStephen B Duffull
Jul 12, 2013·Journal of Pharmacokinetics and Pharmacodynamics·Dinko RekićUlrika S H Simonsson
Apr 6, 2006·Journal of Biopharmaceutical Statistics·Kayode OgungbenroGordon Graham
Dec 16, 2005·The AAPS Journal·Peter L Bonate
Jun 30, 2009·Journal of Pharmacokinetics and Pharmacodynamics·Julie BertrandFrance Mentré
Jan 28, 2010·Basic & Clinical Pharmacology & Toxicology·Leon Aarons, Kayode Ogungbenro
Nov 22, 2012·Journal of Clinical Pharmacy and Therapeutics·R C Milán SegoviaS Romano Moreno
Jul 28, 2013·CPT: Pharmacometrics & Systems Pharmacology·K E KarlssonM O Karlsson
Jan 13, 2015·Paediatric Anaesthesia·Jessica K RobertsCatherine M T Sherwin
Dec 22, 2017·Journal of Clinical Pharmacy and Therapeutics·V Lima-RogelS Romano-Moreno
Nov 19, 2004·Drug Metabolism and Pharmacokinetics·Susumu NakadeShun Higuchi
Nov 15, 2003·Journal of Clinical Pharmacology·Brian P Booth, Jogarao V S Gobburu
May 3, 2008·Journal of Clinical Pharmacy and Therapeutics·V Lima-RogelS Romano-Moreno
Apr 9, 2017·Journal of Pharmacokinetics and Pharmacodynamics·Rasmus Vestergaard JuulTrine Meldgaard Lund
Jun 14, 2005·British Journal of Clinical Pharmacology·Trevor N Johnson
May 17, 2008·European Journal of Clinical Pharmacology·Kayode Ogungbenro, Leon Aarons
Jun 27, 2015·The AAPS Journal·Chakradhar V Lagishetty, Stephen B Duffull
Aug 14, 2020·The Journal of Antimicrobial Chemotherapy·Cornelis SmitCatherijne A J Knibbe
May 6, 2021·CPT: Pharmacometrics & Systems Pharmacology·Chao ChenMats O Karlsson

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.