SwePub - sökning: onr:"swepub:oai:DiVA.org:uu-13...

Numrering	Referens	Omslagsbild	Hitta
1.	Karlsson, Kristin E, et al. (författare) Comparisons of Analysis Methods for Proof-of-Concept Trials 2013 Ingår i: CPT. - : Wiley. - 2163-8306. ; 2, s. e23- Tidskriftsartikel (refereegranskat)abstract Drug development struggles with high costs and time consuming processes. Hence, a need for new strategies has been accentuated by many stakeholders in drug development. This study proposes the use of pharmacometric models to rationalize drug development. Two simulated examples, within the therapeutic areas of acute stroke and type 2 diabetes, are utilized to compare a pharmacometric model–based analysis to a t-test with respect to study power of proof-of-concept (POC) trials. In all investigated examples and scenarios, the conventional statistical analysis resulted in several fold larger study sizes to achieve 80% power. For a scenario with a parallel design of one placebo group and one active dose arm, the difference between the conventional and pharmacometric approach was 4.3- and 8.4-fold, for the stroke and diabetes example, respectively. Although the model-based power depend on the model assumptions, in these scenarios, the pharmacometric model–based approach was demonstrated to permit drastic streamlining of POC trials.

Karlsson, Kristin E, et al. (författare)
Comparisons of Analysis Methods for Proof-of-Concept Trials
2013
Ingår i: CPT. - : Wiley. - 2163-8306. ; 2, s. e23-
Tidskriftsartikel (refereegranskat)abstract
- Drug development struggles with high costs and time consuming processes. Hence, a need for new strategies has been accentuated by many stakeholders in drug development. This study proposes the use of pharmacometric models to rationalize drug development. Two simulated examples, within the therapeutic areas of acute stroke and type 2 diabetes, are utilized to compare a pharmacometric model–based analysis to a t-test with respect to study power of proof-of-concept (POC) trials. In all investigated examples and scenarios, the conventional statistical analysis resulted in several fold larger study sizes to achieve 80% power. For a scenario with a parallel design of one placebo group and one active dose arm, the difference between the conventional and pharmacometric approach was 4.3- and 8.4-fold, for the stroke and diabetes example, respectively. Although the model-based power depend on the model assumptions, in these scenarios, the pharmacometric model–based approach was demonstrated to permit drastic streamlining of POC trials.

Träfflista för sökning "onr:"swepub:oai:DiVA.org:uu-132777" "