Comparisons of Analysis Methods for Proof-of-Concept Trials.
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ABSTRACT:
SUBMITTER: Karlsson KE
PROVIDER: S-EPMC3600728 | biostudies-literature | 2013 Jan
REPOSITORIES: biostudies-literature
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Comparisons of Analysis Methods for Proof-of-Concept Trials.
Karlsson K E KE Vong C C Bergstrand M M Jonsson E N EN Karlsson M O MO
CPT: pharmacometrics & systems pharmacology 20130116
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 ...[more]
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