Journal
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Volume 87, Issue 9, Pages 3388-3397Publisher
WILEY
DOI: 10.1111/bcp.14760
Keywords
clinical pharmacology; COVID; infectious diseases; model-informed drug development; pandemic; pharmacometrics; repurposing
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Funding
- Bill and Melinda Gates Foundation
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This article discusses the five steps of model-informed drug repurposing (MIDR) and categorizes activities under these steps into three stages. MIDR helps extract more information from emerging data and integrate disparate data into actionable insights.
During a pandemic caused by a novel pathogen (NP), drug repurposing offers the potential of a rapid treatment response via a repurposed drug (RD) while more targeted treatments are developed. Five steps of model-informed drug repurposing (MIDR) are discussed: (i) utilize RD product label and in vitro NP data to determine initial proof of potential, (ii) optimize potential posology using clinical pharmacokinetics (PK) considering both efficacy and safety, (iii) link events in the viral life cycle to RD PK, (iv) link RD PK to clinical and virologic outcomes, and optimize clinical trial design, and (v) assess RD treatment effects from trials using model-based meta-analysis. Activities which fall under these five steps are categorized into three stages: what can be accomplished prior to an NP emergence (preparatory stage), during the NP pandemic (responsive stage) and once the crisis has subsided (retrospective stage). MIDR allows for extraction of a greater amount of information from emerging data and integration of disparate data into actionable insight.
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