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  1. Journal of Pharmacokinetics and Pharmacodynamics
  2. Journal of Pharmacokinetics and Pharmacodynamics : Volume 40
  3. Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 4, August 2013
  4. Model based design and analysis of phase II HIV-1 trials
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Journal of Pharmacokinetics and Pharmacodynamics : Volume 44
Journal of Pharmacokinetics and Pharmacodynamics : Volume 43
Journal of Pharmacokinetics and Pharmacodynamics : Volume 42
Journal of Pharmacokinetics and Pharmacodynamics : Volume 41
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 6, December 2013
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 5, October 2013
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 4, August 2013
Introduction to the analysis of PET data in oncology
Incorporation of ABCB1-mediated transport into a physiologically-based pharmacokinetic model of docetaxel in mice
A general model-based design of experiments approach to achieve practical identifiability of pharmacokinetic and pharmacodynamic models
A semi-mechanistic red blood cell survival model provides some insight into red blood cell destruction mechanisms
Sex related differences on valproic acid pharmacokinetics after oral single dose
Model based design and analysis of phase II HIV-1 trials
Challenges of a mechanistic feedback model describing nicotinic acid-induced changes in non-esterified fatty acids in rats
A new mathematical pharmacodynamic model of clonogenic cancer cell death by doxorubicin
Considerations for the prediction of survival time in pancreatic cancer based on registry data
Mixed-effects beta regression for modeling continuous bounded outcome scores using NONMEM when data are not on the boundaries
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 3, June 2013
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 1, Supplement,May 2013
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 2, April 2013
Journal of Pharmacokinetics and Pharmacodynamics : Volume 40, Issue 1, February 2013
Journal of Pharmacokinetics and Pharmacodynamics : Volume 39
Journal of Pharmacokinetics and Pharmacodynamics : Volume 38
Journal of Pharmacokinetics and Pharmacodynamics : Volume 37
Journal of Pharmacokinetics and Pharmacodynamics : Volume 36
Journal of Pharmacokinetics and Pharmacodynamics : Volume 35
Journal of Pharmacokinetics and Pharmacodynamics : Volume 34
Journal of Pharmacokinetics and Pharmacodynamics : Volume 33
Journal of Pharmacokinetics and Pharmacodynamics : Volume 32
Journal of Pharmacokinetics and Pharmacodynamics : Volume 31
Journal of Pharmacokinetics and Pharmacodynamics : Volume 30
Journal of Pharmacokinetics and Pharmacodynamics : Volume 29
Journal of Pharmacokinetics and Pharmacodynamics : Volume 28
Journal of Pharmacokinetics and Pharmacodynamics : Volume 27
Journal of Pharmacokinetics and Pharmacodynamics : Volume 26
Journal of Pharmacokinetics and Pharmacodynamics : Volume 25

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Model based design and analysis of phase II HIV-1 trials

Content Provider SpringerLink
Author Rekić, Dinko Röshammar, Daniel Simonsson, Ulrika S. H.
Copyright Year 2013
Abstract This work explores the advantages of a model based drug development (MBDD) approach for the design and analysis of antiretroviral phase II trials. Two different study settings were investigated: (1) a 5-arm placebo-controlled parallel group dose-finding/proof of concept (POC) study and (2) a comparison of investigational drug and competitor. Studies were simulated using a HIV-1 dynamics model in NONMEM. The Monte-Carlo Mapped Power method determined the sample size required for detecting a dose–response relationship and a significant difference in effect compared to the competitor using a MBDD approach. Stochastic simulation and re-estimation were used for evaluation of model parameter precision and bias given different sample sizes. Results were compared to those from an unpaired, two-sided t test and ANOVA (p ≤ 0.05). In all scenarios, the MBDD approach resulted in smaller study sizes and more precisely estimated treatment effect than conventional statistical analysis. Using a MBDD approach, a sample size of 15 patients could be used to show POC and estimate ED$_{50}$ with a good precision (relative standard error, 25.7 %). A sample size of 10 patients per arm was needed using the MBDD approach for detecting a difference in treatment effect of ≥20 % at 80 % power, a 3.4-fold reduction in sample size compared to a t test. The MBDD approach can be used to achieve more precise dose–response characterization facilitating decision making and dose selection. If necessitated, the sample size needed to reach a desired power can potentially be reduced compared to traditional statistical analyses. This may allow for comparison against competitors already in early clinical studies.
Starting Page 487
Ending Page 496
Page Count 10
File Format PDF
ISSN 1567567X
Journal Journal of Pharmacokinetics and Pharmacodynamics
Volume Number 40
Issue Number 4
e-ISSN 15738744
Language English
Publisher Springer US
Publisher Date 2013-07-11
Publisher Place Boston
Access Restriction One Nation One Subscription (ONOS)
Subject Keyword Monte-Carlo Mapped Power Power Model based drug development Phase II HIV Pharmacology/Toxicology Pharmacy Veterinary Medicine Biomedical Engineering Biochemistry
Content Type Text
Resource Type Article
Subject Pharmacology
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