Author name: fdspharmacynotes

Quality Control and Standardization of Herbal Unit 1 Notes Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and

Pharmacovigilance Unit 5 Notes Pharmacogenomics of adverse drug reactionsGenetics related ADR with example focusing PK parameters. Drug safety evaluation in

Pharmacovigilance Unit 4 Notes Safety data generationPreclinical phaseClinical phasePostapproval phase (PMS) ICH Guidelines for PharmacovigilanceOrganization and objectives of ICHExpedited reportingIndividual

Pharmacovigilance Unit 3 Notes Vaccine safety surveillanceVaccine PharmacovigilanceVaccination failureAdverse events following immunization Pharmacovigilance methodsPassive surveillance– Spontaneous reports and case seriesStimulated

Pharmacovigilance Unit 2 Notes Drug and disease classificationAnatomical, therapeutic and chemical classification of drugsInternational classification of diseasesDaily defined dosesInternational Non

Pharmacovigilance Unit 1 Notes Introduction to PharmacovigilanceHistory and development of PharmacovigilanceImportance of safety monitoring of MedicineWHO international drug monitoring programmePharmacovigilance

Pharmaceutical Regulatory Science Unit 5 Notes Regulatory ConceptsBasic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code

Pharmaceutical Regulatory Science Unit 4 Notes Clinical trialsDeveloping clinical trial protocols, Institutional Review Board / Independent Ethics committee- formation and

Pharmaceutical Regulatory Science Unit 3 Notes Registration of Indian drug product in overseas marketProcedure for export of pharmaceutical products, Technical

Pharmaceutical Regulatory Science Unit 2 Notes Regulatory Approval ProcessApproval processes and timelines involved in Investigational New Drug (IND), New Drug