Keywords: Mutagenic impurity; Control strategy; ICH M7; Gas chromatography; HPLC; NMR;
مقالات ISI (ترجمه نشده)
مقالات زیر هنوز به فارسی ترجمه نشده اند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: ICH Q3A; ICH Q3B; ICH Q3C; ICH M7; Impurity safety; Non-mutagenic impurities; Impurity qualification; 1Â mg/day; TTC; Haber's law;
Keywords: Negative predictions; (Q)SAR; Expert system; In silico toxicology; Expert assessment; ICH M7;
Keywords: ICH M7; Computational toxicology; Genotoxic impurities; Structure-activity relationships;
Keywords: Genotoxic impurities; In silico; (Q)SAR; Mutagenicity; ICH M7;
A consortium-driven framework to guide the implementation of ICH M7 Option 4 control strategies
Keywords: ICH M7; Expert review; Purge; Mutagenic impurity; Purge Ratio; Mirabilis;
Utility of published DNA reactivity alerts
Keywords: Mutagenicity; Ames test; Expert review; Derek Nexus; Sarah Nexus; ICH M7; QSAR;
Carbamates and ICH M7 classification: Making use of expert knowledge
Keywords: Carbamates; Mutagenicity; Ames test; Expert review; Derek Nexus; Sarah Nexus; ICH M7; (Q)SAR;
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses
Keywords: ICH M7; Impurities; (Q)SAR; Mutagenic impurities; Ames test; Toxicity databases; Expert review;
Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity
Keywords: ICH M7; Pharmaceutical impurities; Mutagenicity; (Q)SAR; Aromatic amines; SAR fingerprint;
Evaluation of a statistics-based Ames mutagenicity QSAR model and interpretation of the results obtained
Keywords: In silico; QSAR; Mutagenicity; ICH M7; Sarah nexus;
Establishing best practise in the application of expert review of mutagenicity under ICH M7
Keywords: ICH M7; Ames; Genotoxicity; Mutagenicity; Expert rule-based; Statistical; In silico;
(Q)SAR assessments of potentially mutagenic impurities: A regulatory perspective on the utility of expert knowledge and data submission
Keywords: Drug impurities; Mutagenicity; (Q)SAR; ICH M7;
Validation of Toxtree and SciQSAR in silico predictive software using a publicly available benchmark mutagenicity database and their applicability for the qualification of impurities in pharmaceuticals
Keywords: ICH M7; Mutagenicity; Qualification of impurities; QSAR; SAR; Pharmaceuticals; False negatives; SciQSAR; Toxtree;