Biostatisitcs And Research Methodology 8 Semester Notes

BP801T. BIOSTATISTICS AND RESEARCH METHODOLOGY (Theory)

Scope: To understand the applications of Biostatics 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 Clinical trials and Observational and Experimental studies, SPSS, R, and MINITAB statistical software, analyzing the statistical data using Excel.

Objectives: 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 statistica l problems
•  Appreciate statistical techniques in solving problems. Course content:

All unit 1          All unit 2

Unit-I  

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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

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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 hypothesis, sampling, the essence of sampling, types of sampling, Error-I type, Error-II type, Standard the error of the 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

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

Introduction to Research: Need for research, Need for the 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

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

Unit-V

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Design and Analysis of Experiments: 

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

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

Recommended Books (Latest edition):

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton, publisher Marcel Dekker 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