Lv21
118 积分 2023-09-08 加入
N-Nitrosamine Drug Substance Related Impurities (NDSRIs) – A proposal for the addition of subcategories to Carcinogenic Potency Categorisation Approach categories 1 and 2 for NDSRIs with a molecular weight > 200 Da
3天前
已完结
On the role of digital tools in nitrosamine risk assessment for drug substance and drug product manufacturing processes
3天前
已完结
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products
3天前
已完结
Confidence score calculation for the carcinogenic potency categorization approach (CPCA) predictions for N-nitrosamines
3天前
已完结
Safety assessment of drug impurities for patient safety: a comprehensive review
3天前
已完结
Deriving acceptable limits for non-mutagenic impurities in medicinal products – Durational adjustments
3天前
已完结
Regulatory Toxicology and Pharmacology New limits proposed for the management of non-mutagenic impurities
3天前
已完结
Antibody-Drug Conjugate Overview: a State-of-the-art Manufacturing Process and Control Strategy
5个月前
已完结
Strategy to Assess and Control Nitrosamine Formation in API during Storage: A Sitagliptin Case Study
5个月前
已完结
Discovery of First Branched-Chain Ketoacid Dehydrogenase Kinase (BDK) Inhibitor Clinical Candidate PF-07328948
5个月前
已完结
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