Applying ICH S1B(R1) in 5 steps: Carcinogenicity assessment made simple with Kaptis
Carcinogenicity assessment is a critical step in drug development. Teams must balance regulatory compliance, development timelines, and ethical testing, often with incomplete datasets. The revised ICH S1B(R1) guideline introduces a weight-of-evidence (WoE) approach that provides a more structured, efficient, and human-relevant path forward. By applying this framework, organisations can benefit from: $2 – 4M cost […]
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