Category: Pharmacovigilance

MedDRA or Medical Dictionary for Regulatory Activities; Standardized MedDRA Queries; Pharmacovigilance Notes Unit 2 B.Pharm 8 Semester

MedDRA or Medical Dictionary for Regulatory Activities A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus […]

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Anatomical Therapeutic Chemical (ATC) classification system, Pharmacovigilance Notes Unit 2 B.Pharm 8 Semester

Anatomical Therapeutic Chemical (ATC) classification system Structure In the Anatomical Therapeutic Chemical (ATC) classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Drugs […]

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Introduction to adverse drug reactions, Definitions and classification of ADRs & Adverse Drug Reactions Classification

Key Definitions & Adverse Drug Reactions Classification Adverse drug reaction (ADR)—The World Health Organization defines an ADR as “any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, […]

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Drug Safety in Pediatric Population | Part-2 | Drug Safety Specific Population | Pharmacovigilance

Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for […]

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