Key Aspects of Modern, Quantitative Drug Development

Eric Gibson, Frank Bretz (), Michael Looby and Bjoern Bornkamp
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Eric Gibson: Novartis Pharmaceuticals
Frank Bretz: Novartis Pharma AG
Michael Looby: Novartis Pharma AG
Bjoern Bornkamp: Novartis Pharma AG

Statistics in Biosciences, 2018, vol. 10, issue 2, No 2, 283-296

Abstract: Abstract One of the main goals of modern drug development is customized care, where doctors match the right patient to the right treatment at the right dose, based on quantitative evidence. In this paper we review three key aspects of drug development that are critical towards achieving this goal. More specifically, we discuss (i) the advantages of modern model-based dose-finding as opposed to traditional pairwise comparisons, (ii) the value of pharmacometrical modeling, understanding the variability in how patients metabolize, tolerate, and respond to drugs, and (iii) the potential impact of enrichment strategies to identify study populations that are most likely to benefit from the investigational drug under development.

Keywords: Enrichment; Predictive analytics; Dose-finding; Pharmacometrics; MCP-Mod (search for similar items in EconPapers)
Date: 2018
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DOI: 10.1007/s12561-017-9203-2

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