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).
URL:
https://pharmacode.vercel.app/syllabus/semester-7/bp701t-biostatistics-research-methodology/Unit-wise Syllabus
5 Units1
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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Other subjects in Semester 7
BP702TCosmetics and CosmeceuticalsBP703TAI in Clinical ApplicationsBP704TModern Analytical TechniquesBP705TPharmacovigilanceBP706TPharmacy PracticeBP707TRegulatory AffairsBP708T AECAEC Elective (cGMP / Pharmaceutical Automation / Cellular Biology / Medical Devices / Food Waste Products / Biosimilars)BP709PModern Analytical Techniques (Practical)BP710RPResearch Project (Major)