weight of evidence
- Guideline or reference source
- ICHS11 ICHS11 NONCLINICAL SAFETY TESTING IN SUPPORT OF
- Definition
- An approach that evaluates information from several sources to decide if there is sufficient evidence to support the development of pharmaceuticals for paediatric use or whether additional nonclinical testing is warranted to address potential safety concerns. The weight given to the available evidence depends on factors such as the quality of the data, consistency of results, nature and severity of effects, and relevance of the information. The weight of evidence approach requires use of scientific judgment and, therefore, should consider the robustness and reliability of the different data sources.
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