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A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials.

ABSTRACT: Multiple components factor into the assessment of combination safety risks when two or more novel individual products are used in combination in clinical trials. These include, but are not limited to, biology, biochemistry, pharmacology, class effects, and preclinical and clinical findings (such as adverse drug reactions, drug target and mechanism of action, target expression, signaling, and drug-drug interactions). This paper presents a science-based methodology framework for the assessment of combination safety risks when two or more investigational products are used in clinical trials. The aim of this methodology framework is to improve prediction of the risks, to enable the appropriate safety risk mitigation and management to be put in place for the combination, and the development of the project combination safety strategy.

SUBMITTER: Patera AC

PROVIDER: S-EPMC10205853 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials.

Patera Andriani C AC Maidment Julie J Maroj Brijesh B Mohamed Ahmed A Twomey Ken K

Pharmaceutical medicine 20230426 3

Multiple components factor into the assessment of combination safety risks when two or more novel individual products are used in combination in clinical trials. These include, but are not limited to, biology, biochemistry, pharmacology, class effects, and preclinical and clinical findings (such as adverse drug reactions, drug target and mechanism of action, target expression, signaling, and drug-drug interactions). This paper presents a science-based methodology framework for the assessment of ...[more]

PMID: 37099245

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Dataset Information

A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials.

Publications

A Science-Based Methodology Framework for the Assessment of Combination Safety Risks in Clinical Trials.

Similar Datasets

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