Instem will host an ICH S1B and data sharing session at Eurotox 2023.
Tag archives: ICH S1B
Target carcinogenicity assessment
The recently introduced ICH S1B addendum1 (integrated with the original S1B guideline on 4th August 2022) includes a new weight of evidence (WoE) assessment to determine whether performing a 2-year rat study would add value to the assessment of human carcinogenic risk. The guideline describes six WoE factors – [1] target biology, [2] secondary pharmacology, [3] …
Society of Toxicology 2023 Meeting
Instem’s In Silico summary for SOT 2023.
Assessing carcinogenicity risk of nitrosamines and supporting the ICH S1B guideline
At this year’s SOT in Nashville (March 19-23, 2023), Instem will be organizing two workshops related to cancer assessments.1 In the first workshop, to be held on Tuesday, March 21, 4:30 PM – 5:30 PM (CT) in Room 101B, we will discuss carcinogenicity assessments aligned with the ICH S1B guideline2, specifically focusing on the weight …
A protocol to support the weight-of-evidence for human carcinogenicity assessment of pharmaceuticals
This week we are pleased to welcome Dr. Arianna Bassan as a guest contributor to the blog. The recently published draft addendum of the ICH S1B guideline1 introduces a weight-of-evidence (WoE) approach to assess human carcinogenic potential of small molecule pharmaceuticals and determine whether a 2-year rat carcinogenicity study would add value. Application of this …