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E1: Clinical Safety for Drugs used in Long Term Treatment E1: The Extent Of Population Exposure To Assess Clinical Safety for Drugs intended for long term treatment of non-life threatening conditions. E2A-E2F: Pharmacovigilance E2A: Clinical Safety Data Management: Definitions and…
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…
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…
ICH, or the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, is what the acronym stands for. ICH is a collaborative effort in which regulators from Europe, Japan, and the United States participate in…
How to for GPAT| Strategy| Syllabus| Books| Important Books What is GPAT Exam? A national level entrance exam, the Graduate Pharmacy Aptitude Test (GPAT), is required for enrollment in the M. Pharma. programme. Up till 2018, the All India Council…
CSIR-CDRI is a unique R & D Institution in the country with state of the art infrastructure for new drug discovery and development from “Concept to Commercialization”. It is poised to become a global leader through cutting edge science &…
WHO defined Pharmacovigilance as ‘the pharmacological science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem‘. It focuses primarily on adverse medication reactions, to put it simply. It also addresses medical blunders such overdosing, misusing, and abusing a certain medicine. These precautions are made to prevent certain harmful effects in a patient.
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