Applying Expert Knowledge for ICH M7 Classification - Session 2

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In Session 2 of this 3 part series, two presentations are given that address various case studies in detail with attention to multiple factors that inform classification or next steps.
Presentation 1: Alejandra Trejo-Martin, Gilead Sciences
Presentation 2: Sebastian Joseph, Pharmalex India

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3 окт 2024

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Комментарии : 5

@yomudon2 4 года назад

Session 2 was also fun for me. Most aldehydes are negative in QSAR, and it sometimes bothers me like Case study#3. As you mentioned(50:19), it should be handled correctly. And the ames negative compound with clastogenicity is referred as class 5 in ICH M7 Q&A(step 2b). By the way, the interim limit of DIPNA in EMA is the same as NDEA. With considering the form of diazonium ion, it looks conservative approach. What do you think about it?

@sebastianjoseph6279 4 года назад

In any risk assessment, the objective is to ensure safety of patients, therefore are designed to be sufficiently health protective, and as you may know, every risk assessment is associated with some uncertainty. This uncertainty will be increased when you use surrogate approach (as you do not have compound-specific data). Due to this, the risk assessor usually lean towards health protection and therefore limit derived using surrogate data is expected to be conservative than when derived using compound-specific data.

@yomudon2 4 года назад

@@sebastianjoseph6279 Thank you for your kind and helpful answer. I perfectly agree with you. In other words, how to manage uncertainty is very important in risk assessment. I'll keep it in mind.