Discover an informative webinar that focuses on how the KnowledgeScan™ solution is advancing drug safety applications, including Target Safety and Weight of Evidence Assessments in accordance with the addendum to the International Council for Harmonisation (ICH) S1B (R1) guideline on testing for carcinogenicity of pharmaceuticals.
The solution rapidly generates TSAs to identify potential adverse effects of target modulation, while the WoE assessment can potentially avoid the need for the two-year rat carcinogenicity study. This approach not only enhances ethical standards but also offers considerable financial savings by minimizing reliance on long-term animal testing.
In this webinar, the expert speakers will show how the KnowledgeScan™ solution uses an ‘augmented intelligence’ approach to thoroughly understand target biology and its safety implications. This includes an extensive literature review, bioinformatics profiling, pharmacological analysis and expert synopsis. Translational informatics integrates data, information and knowledge from research, development and clinical practice, supporting translational science and medicine.
The goal in producing TSAs is to leverage relevant information from across the research and development (R&D) continuum and combine data from clinical practice and molecular-focused laboratory research. The speakers will also present the latest TSA workflow developments, featuring significant improvements in speed and scale and greater adoption of findability, accessibility, interoperability, and reusability (FAIR) data principles.
Conventionally, TSAs are conducted during early-stage development. However, later in development, the content of the TSA can serve as the substrate for WoE documentation, in accordance with the Addendum to the ICH S1B (R1) guideline, to determine whether a two-year rat study would add value to the assessment of human carcinogenic risk.
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Register for this webinar today to understand what is required to make robust, evidence-based documentation for effective safety assessment submissions.
Keywords: Drug Development, Drug Discovery, Clinical Research, Drug Safety, Pharmacovigilance, Regulatory, ICH, Safety Assessment, Toxicology/Safety