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BP701TSemester 73 creditsTheory

Biostatistics Research Methodology

Complete unit-wise syllabus for BP701T as per the PCI B.Pharm NEP 2020 curriculum (Semester 7 — Pharmacovigilance + Regulatory + Research).

All Sem 7 Subjects
URL:https://pharmacode.in/syllabus/semester-7/bp701t-biostatistics-research-methodology/

Unit-wise Syllabus

5 Units
1
Research Design9 Hours
  • Research design types: observational (cross-sectional, cohort, case-control) vs. experimental (RCT, quasi-experimental); hierarchy of evidence; systematic reviews and meta-analysis
  • Study protocol development: research question (PICO format), hypothesis formulation, primary and secondary endpoints, sample size rationale
  • Bias in research: selection bias, information bias, confounding; strategies to minimise bias; randomisation and blinding methods
2
Sampling Methods and Sample Size9 Hours
  • Sampling techniques: probability sampling (simple random, stratified, systematic, cluster) and non-probability sampling (convenience, purposive, snowball)
  • Sample size calculation: for means (t-test), proportions (chi-square), survival analysis; alpha, beta, power; software tools (G*Power, PASS)
  • Randomisation methods: simple, block, stratified, adaptive randomisation; allocation concealment; CONSORT guidelines for reporting RCTs
3
Advanced Statistical Tests9 Hours
  • Non-parametric tests: Mann-Whitney U test, Wilcoxon signed-rank test, Kruskal-Wallis test, Friedman test; when to use non-parametric vs. parametric tests
  • Survival analysis: Kaplan-Meier curves; log-rank test; Cox proportional hazards model; hazard ratio; applications in clinical research
  • Multivariate analysis: multiple regression, logistic regression, discriminant analysis; confounding adjustment; interaction effects
4
Clinical Research and GCP9 Hours
  • Clinical research phases: I-IV; study design for each phase; endpoints (primary, secondary, surrogate, patient-reported outcomes)
  • ICH E6 Good Clinical Practice (GCP) guidelines: principles; responsibilities of sponsor, investigator, IRB/IEC; informed consent process; monitoring, auditing, inspection
  • Regulatory requirements for clinical trials in India: New Drugs and Clinical Trials Rules 2019; CTRI registration; data integrity; safety reporting timelines
5
Scientific Writing and Research Dissemination9 Hours
  • Scientific writing: IMRAD format (Introduction, Methods, Results, Discussion); abstract writing; research article structure; avoiding plagiarism
  • Systematic review and meta-analysis: PRISMA guidelines; search strategy; inclusion/exclusion criteria; data extraction; heterogeneity assessment (I2 statistic); forest plots
  • Research dissemination: journal selection (impact factor, quartile ranking, predatory journals); peer review process; oral and poster presentations; grant writing basics

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  • Reference textbooks and recommended reading list
  • Previous year question papers (PYQ)
  • Topic-wise short notes and revision summaries
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