Course Title: 
Biostatisitics and Research Methodology - Theory
Course Code: 
Year Taught: 
Undergraduate (UG)
School of Pharmacy

'Biostatisitics and Research Methodology - Theory' is a course offered in the eighth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours


To understand the applications of Biostatistics in Pharmacy. This subject deals with descriptive statistics, Graphics, Correlation, Regression, logistic regression, Probability theory, Sampling technique, Parametric tests, Non Parametric tests, ANOVA, Introduction to Design of Experiments, Phases of Clini- cal trials and Observational and Experimental studies, SPSS, R and MINITAB statistical software’s, analyz- ing the statistical data using Excel.


Upon completion of the course the student shall be able to:

  1. Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of Experiment)
  2. Know the various statistical techniques to solve statistical problems
  3. Appreciate statistical techniques in solving the problems.

Unit I (10 Hours)

Introduction: Statistics, Biostatistics, Frequency distribution Measures of central tendency: Mean, Medi- an, Mode- Pharmaceutical examples

Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical problems Correlation: Definition, Karl Pearson’s coefficient of correlation, Multiple correlation - Pharmaceuticals examples

Unit II (10 Hours)

Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x = a + by, Multiple regression, standard error of regression– Pharmaceutical Examples

Probability: Definition of probability, Binomial distribution, Normal distribution, Poisson’s distribution, properties - problems Sample, Population, large sample, small sample, Null hypothesis, alternative hypoth- esis, sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard error of mean (SEM) - Pharmaceutical examples

Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way and Two way), Least Significance difference

Unit III (10 Hours)

Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis test, Friedman Test

Introduction to Research: Need for research, Need for design of Experiments, Experimental Design Tech- nique, plagiarism

Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph

Designing the methodology: Sample size determination and Power of a study, Report writing and presen- tation of data, Protocol, Cohorts studies, Observational studies, Experimental studies, Designing clinical trial, various phases.

Unit IV (10 Hours)

Blocking and confounding system for Two-level factorials

Regression modeling: Hypothesis testing in Simple and Multiple regression models

  • Introduction to Practical components of Industrial and Clinical Trials Problems:
    Introduction and sale of over the counter, and Rational use of common over the counter medicationStatistical Analysis Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R - Online Statistical Software’s to Industrial and Clinical trial approach.
  • Unit V (07 Hours)

    Design and Analysis of experiments:

    Factorial Design: Definition, 22, 23 design. Advantage of factorial design

    Response Surface methodology: Central composite design, Historical design, Optimization Techniques

    Recommended Books (Latest Editions)

    1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher Marcel Dek- ker Inc. NewYork.
    2. Fundamental of Statistics – Himalaya Publishing House- S.C.Guptha
    3. Design and Analysis of Experiments –PHI Learning Private Limited, R. Pannerselvam,
    4. Design and Analysis of Experiments – Wiley Students Edition, Douglas and C. Montgomery