B.Pharmacy Semester 8

Semester 8 – Outline of Subjects and Units

Biostatistics & Research Methodology

• Unit I: Introduction & Data Types
  Qualitative vs. quantitative data, scales of measurement

• Unit II: Measures of Central Tendency & Dispersion
  Mean, median, mode; variance, standard deviation, coefficient of variation

• Unit III: Probability & Distributions
  Basic probability rules; normal, binomial, Poisson distributions

• Unit IV: Hypothesis Testing & Significance
  Null vs. alternative hypotheses, Type I/II errors; t‑test, chi‑square, ANOVA

• Unit V: Research Design & Ethics
  Observational vs. experimental studies; case‑control/cohort designs; clinical trial phases; informed consent

Social & Preventive Pharmacy

• Unit I: Concepts of Health & Disease
  Definitions of health; social, psychological, cultural determinants

• Unit II: Epidemiology & Disease Control
  Measures of disease frequency; outbreak investigation; immunization strategies

• Unit III: National Health Programs
  TB, malaria, HIV/AIDS, immunization initiatives; pharmacist’s role

• Unit IV: Health Education & Communication
  Designing IEC materials; counseling techniques; mass media campaigns

• Unit V: Community Health & Environment
  Water/sanitation, waste management, disaster preparedness

Pharmaceutical Regulatory Science

• Unit I: Regulatory Frameworks
  CDSCO, US FDA, EMA structure and functions

• Unit II: Drug Approval Processes
  IND, NDA, ANDA pathways; clinical trial requirements

• Unit III: ICH Guidelines & Quality Systems
  Q-series guidelines; GMP, GLP, GDP fundamentals

• Unit IV: Intellectual Property Rights
  Patents, trademarks, data exclusivity; CTD/eCTD dossier format

• Unit V: Regulation of Devices & Cosmetics
  Classification, standards, labeling requirements

Pharmacovigilance

• Unit I: Foundations of PV
  History, scope, terminology (ADR, AE, SAE)

• Unit II: ADR Detection & Reporting
  Causality assessment scales; spontaneous vs. solicited reporting

• Unit III: Signal Detection & Risk Management
  Data mining methods; Risk Evaluation and Mitigation Strategies (REMS)

• Unit IV: Pharmacoepidemiology Methods
  Cohort, case‑control, database studies; incidence/prevalence measures

• Unit V: Global PV Systems
  UMC‑WHO programme, EudraVigilance, FDA FAERS

Quality Control & Standardization of Herbals

• Unit I: Raw Material Authentication
  Macroscopic, microscopic, chemical identification

• Unit II: Adulteration & Contaminant Testing
  Heavy metals, pesticides, microbial limits

• Unit III: Phytochemical Evaluation
  Qualitative & quantitative assays; TLC, HPTLC fingerprinting

• Unit IV: Chromatographic & Spectroscopic Methods
  HPLC, GC, UV–Vis methods for marker compounds

• Unit V: Regulatory Guidelines
  WHO, ICH, AYUSH standards; documentation for herbal products

Project Work

• Research Planning & Protocol Development
  Literature review, objective setting, study design

• Experimental/Field Work
  Data collection, lab experiments, community surveys

• Data Analysis & Interpretation
  Statistical tools, result synthesis

• Report Writing & Presentation
  Thesis preparation, viva‑voce coordination

Elective (Choose One)

• Pharma Marketing Management

  1. Marketing environment & strategies

  2. Segmentation, targeting & positioning

  3. Product lifecycle & brand management

  4. Pricing, promotion & distribution channels

  5. Digital marketing & ethical considerations

🔖 What You’ll Get in Each Subject Page

• Concise Unit Notes – Key points, tables, and chart summaries

• Practice Questions – MCQs, short answers, and case‑based scenarios

• Visual Aids – Flowcharts for research design, epidemiology maps, spectra

• Downloadable Templates – Consent forms, protocol outlines, reporting checklists

💡 Student Tip

Begin with Biostatistics & Research Methodology to strengthen your data‑analysis skills—this foundation will make your Project Work and Pharmacovigilance modules much more manageable.

🔔 Stay Tuned

Keep an eye out for weekly updates: interactive quizzes, sample project abstracts, webinar sessions with industry experts, and high‑yield revision handouts!