Pharmaceutical Regulatory Science — B.Pharmacy 8th Semester
Covers drug regulatory affairs in India (CDSCO, DCG(I)), Drugs and Cosmetics Act 1940, Schedule Y (clinical trials), intellectual property rights (patents, trademarks), ICH guidelines, US FDA approval process, and WHO prequa…
Pharmacovigilance — B.Pharmacy 8th Semester
Covers adverse drug reaction (ADR) classification, signal detection, causality assessment (WHO-UMC, Naranjo scale), Pharmacovigilance Programme of India (PvPI), CIOMS forms, MedDRA terminology, risk management plans, and REMS.
Syll…
Social and Preventive Pharmacy — B.Pharmacy 8th Semester
Covers concepts of health and disease, epidemiology, nutrition and health, national health programs (malaria, TB, HIV, immunization), demography, health education, and environmental sanitation. Essentials for community pharmacy…
Biostatistics and Research Methodology — B.Pharmacy 8th Semester
Covers measures of central tendency and dispersion, probability, parametric tests (t-test, ANOVA, chi-square), non-parametric tests, correlation and regression, sample size determination, research design, clinical trial…