Category: B Pharma

ICH SAFETY GUIDELINES

In order to identify potential dangers including carcinogenicity, genotoxicity, and reprotoxicity, ICH has created a thorough set of safety guidelines. A non-clinical testing approach for determining the QT interval prolongation liability—the leading factor in drug withdrawals in recent years—has made…

ICH QUALITY GUIDELINES

The performance of stability studies, establishing appropriate thresholds for impurity testing, and a more sensible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk assessment are all significant milestones in the harmonisation of the Quality domain. Q1A-Q1F: Stability…

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