Zlecenie 12475692 - Risk Evaluation and Control Strategy for Impurities in...

related to the proprietary clinical phase 1-suitable API manufacturing process: 1. Mutagenicity / Genotoxicity Assessment: 1.1. Conduct genotoxicity and mutagenicity assessment of all identified and potential organic impurities using Lhasa DEREK Nexus and Lhasa SARAH Nexus or equivalent (QSAR) expert rule – based and statistical prediction systems recognized by global regulatory agencies under ICH M7(R2). 1.2. Assess potential structural alerts, supporting conclusions with scientifically justified expert review following ICH M7 guidelines (including classification into Classes 1–5). 1.3. Utilize Lhasa’s Mirabilis or equivalent risk-based modeling tools for purge and likelihood analysis, consistent with ICH M7 recommendations on applying process knowledge and fate/purge principles (optional). 2. Impurity Identification and Process-Based Risk Analysis: 2.

Powstaje w kontekście projektu
FENG.01.01-IP.01-1012/23 - Nowa terapia celowana nowotworów z delecją genu MTAP – II faza / New targeted therapy for tumors with a deletion of the MTAP gene – phase II