Zlecenie 12232795 - Description of the subject of the order: Risk Evaluation and...

led impurities control evaluation services 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 Identifica

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