Pharmacy Freak Editorial Team

The WHO international drug monitoring program MCQs With Answer resource is designed for B. Pharm students to build strong pharmacovigilance foundations. This introduction highlights key concepts: pharmacovigilance, adverse drug reaction (ADR) reporting, the Uppsala Monitoring Centre (UMC), VigiBase, ICSR structure, causality assessment (WHO‑UMC, Naranjo), MedDRA and WHODrug coding, disproportionality methods (PRR, IC), signal detection and … Read more

Drug safety monitoring, or pharmacovigilance, is vital for B. Pharm students to understand post-marketing surveillance, adverse drug reaction (ADR) detection, and risk–benefit assessment. Mastery of pharmacovigilance principles—including spontaneous reporting systems, causality assessment tools (Naranjo, WHO‑UMC), signal detection, regulatory reporting requirements, risk management plans, and pharmacoepidemiology—prepares pharmacists to protect patients and comply with regulations. Familiarity with … Read more

The history and development of pharmacovigilance trace how drug safety evolved from the thalidomide tragedy to sophisticated global systems. This introduction covers key milestones, regulatory initiatives, WHO programmes, Uppsala Monitoring Centre, signal detection, causality assessment (Naranjo, WHO‑UMC), MedDRA coding, spontaneous reporting, post‑marketing surveillance (Phase IV), risk management plans, pharmacovigilance legislation and national programmes like PvPI. … Read more

Purple Book – biosimilars and biologics listing MCQs With Answer provides B. Pharm students an essential guide to regulatory listings, approval pathways, and safety monitoring for biologics and biosimilars. This short introduction covers Purple Book purpose, biosimilar versus reference biologic distinction, FDA listing practices, interchangeability criteria, and post-marketing pharmacovigilance concepts. Emphasis is on analytical similarity, … Read more

Code of Federal Regulations (CFR) overview MCQs With Answer The Code of Federal Regulations (CFR) is the codified body of rules issued by U.S. federal agencies that govern pharmaceutical development, manufacturing, labeling, safety, and distribution. For B. Pharm students, understanding CFR structure—especially Title 21 relating to Food and Drugs—and key parts such as cGMP (21 … Read more