Rasmus Jansson-Löfmark , Markus Fridén , Lassina Badolo , Christine Ahlström , Ian Gurrell , Menelas N. Pangalos , Rhys DO Jones
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Translational PK/PD: a retrospective analysis of performance and impact from a drug portfolio
Attrition in drug development continues to be dominated by failure in clinical mid-stage proof-of-concept studies. Successfully demonstrating proof-of-mechanism (PoM) has been reported to be a key factor to improve clinical success. Accurate prediction and testing of PoM are crucial. This analysis of AstraZeneca’s portfolio assesses the role of translational PK/PD modelling in predicting clinical PoM. It has found that 83% of compounds had drug exposure–response within a threefold prediction accuracy. Notably, projects with robust PK/PD packages achieved an 85% success rate in PoM, compared with 33% for those with basic packages. This highlights how translational PK/PD modelling can significantly enhance success rates for drugs entering clinical trials.
期刊介绍:
Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed.
Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.