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M1 MedDRA Terminology M1: MedDRA- Medical Dictionary for Regulatory Activities M1: PtC WG MedDRA Points to Consider M2 Electronic Standards M2: EWG Electronic Standards for the Transfer of Regulatory Information M3 Nonclinical Safety Studies M3(R2): Guidance on Nonclinical Safety Studies…
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…
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