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- W153984705 abstract "Approximately one third of all drug discontinuation from preclinical discovery to postapproval stage is caused by drug safety, with a large contribution of cardiovascular (CV) safety findings. Moreover, drug-induced QT prolongation and proarrhythmic liabilities have been the main reasons for labeling restrictions and drug withdrawals after approval. Pharmacometric (model-based) tools have become increasingly beneficial to assess CV liabilities, as they allow predictions under new circumstances (new dosing regimen or response in the alternative patient populations), and extrapolations across different systems (e.g., from in vitro or in vivo to clinical). This model-based analysis is particularly important for the pharmaceutical industry as it facilitates selection and progression of the best compounds at early stages, and understanding of the right dose and schedule that is safe to patients via the right clinical study design in clinical development. This chapter provides an overview on how pharmacometrics is used in drug industry to quantify the risk of CV liabilities, with the main focus on QT interval." @default.
- W153984705 created "2016-06-24" @default.
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- W153984705 creator A5052999603 @default.
- W153984705 creator A5077172862 @default.
- W153984705 creator A5087934672 @default.
- W153984705 date "2014-01-01" @default.
- W153984705 modified "2023-10-17" @default.
- W153984705 title "Pharmacometrics in Cardiovascular Safety" @default.
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