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October 2025

KAptis Weight of Evidence ICH S1b(r1)

Applying ICH S1B(R1) in 5 steps: Carcinogenicity assessment made simple with Kaptis

Discuss, Innovate /

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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ICH M7 control option 4: How to confidently demonstrate control of mutagenic impurities in API synthesis (without analytical testing)

Innovate /

If you’re currently relying solely on analytical testing to check for mutagenic impurities in your active pharmaceutical ingredient (API), there is a more time- and cost-effective option available that doesn’t compromise patient safety. Recent data for a medium-sized pharmaceutical company showed that you could save $1.35M annually and reduce time taken by 77%, using in

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