JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

PS801: BIOSTATISTICS AND RESEARCH METHODOLOGY

B.Pharmacy IV Year II Semester (R17)

Course Objectives

To understand the applications of Biostatics in Pharmacy. This subject deals with

descriptive statistics, Graphics, Correlation, Regression, ANOVA, Introduction to Design of Experiments, Phases of Clinical trials and Observational and Experimental studies.

Course Outcomes

Upon completion of the course the student shall be able to

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

UNIT - I

Introduction: Statistics, Biostatistics, Frequency distribution Measures of central tendency: Mean, Median, 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

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. Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis, 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

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, Experiential Design Technique, 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 presentation of data, Protocol, Cohorts studies, Observational studies, Experimental studies, Designing clinical trial, various phases.

UNIT - IV

Introduction to Practical components of Industrial and Clinical Trials Problems: Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN OF EXPERIMENTS, R - Online Statistical Software’s to Industrial and Clinical trial approach

UNIT - V

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

R17 B. PHARMACY IV YEAR

Recommended Books (Latest edition):

  • 1. Pharmaceutical Statistics - Practical and clinical applications, Sanford Bolton, Publisher Marcel Dekker Inc. New York.
  • 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 R17 B. PHARMACY IV YEAR

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