 # BIOSTATISITCS AND RESEARCH METHODOLOGY Teacher

##### Gyanaranjan Parida Category

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# Code(Credit) : BPHT4201 (4-0-0)

## Course Objectives

 CO Statement Mapping with PO CO1 To Know the operation of M.S. Excel, SPSS, R and MINITAB®, DoE (Design of Experiment) PO2, PO3, PO10,PO11 CO2 To Know the various statistical techniques to solve statistical problems PO1, PO2, PO5,PO10 CO3 Appreciate statistical techniques in solving the problems. PO1, PO2, PO5,PO10

## Course Outcomes

• To understand the applications of Biostatics in Pharmacy.
• To deal 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’s, analyzing the statistical data using Excel

## Course Syllabus

Module-1

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 correlations - Pharmaceuticals examples

Module-2

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 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

Module-3

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

Module-4

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

Module-5

Design and Analysis of experiments:
Factorial Design: Definition, 2^2, 2^3design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design, Optimization Techniques

# Session Plan

### Session 1

#### Introduction: Statistics, Biostatistics, Frequency distribution

http://youtu.be/KvTkHxGrCp4

### Session 2

Measures of central tendency: Mean.

http://youtu.be/Dlh8aUzijkg

PDFMEAN

### Session 3

Measures of central tendency: Median, Mode- Pharmaceutical examples

### Session 4

Measures of dispersion: Dispersion, Range,

PDFDISPERSION

### Session 5

Measures of dispersion: Standard deviation, Pharmaceutical problems

PDFSD

### Session 6

Correlation: Definition, Karl Pearson’s coefficient of correlation,

### Session 7

Correlation: Multiple correlation - Pharmaceuticals examples

### Session 8

Regression: Curve fitting by the method of least squares,

REGRESSION

### Session 9

Regression: Curve fitting by the method of least squares,

PDFRegression

### Session 10

Regression: fitting the lines y= a + bx and x = a + by

### Session 11

Regression:Multiple regression, standard error of regression– Pharmaceutical Examples

https://youtu.be/C8bwrXI71zU

### Session 12

Probability:Definition of probability, Binomial distribution

https://youtu.be/ug3q0M6SflM

### Session 13

Probability: Normal distribution, Poisson’s distribution, properties - problems

https://youtu.be/VIH1DL77TN4

### Session 14

Probability: Sample, Population, large sample, small sample

https://youtu.be/wye3zABM9_M

PDFSAMPLING

### Session 15

Probability: Null hypothesis, alternative hypothesis

https://youtu.be/Hjx8kM8UcLU

### Session 16

Probability: sampling, essence of sampling, types of sampling, Error-I type, Error-II type

https://youtu.be/IsevYLt9P5A

### Session 17

Probability: Standard error of mean (SEM) - Pharmaceutical examples

https://youtu.be/J1twbrHel3o

PDF SEMSEMSEM

### Session 18

Parametric test: t-test(Sample, Pooled or Unpaired and Paired) ,

https://youtu.be/_xc-8S5UuTE

PDFT-TEST

### Session 19

Parametric test: ANOVA, (One way and Two way)

https://youtu.be/CgpCybhj6DY

PDFANOVA

### Session 20

Parametric test: Least Significance difference

https://youtu.be/_xc-8S5UuTE

PDFLSD

### Session 21

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

https://youtu.be/1hgEfQuP_HE

https://youtu.be/fEobVCV2TJE

### Session 22

Non Parametric tests: Kruskal-Wallis test, Friedman Test

https://youtu.be/GngkLlen-LM

https://youtu.be/-m14v1tusLY

### Session 23

Introduction to Research: Need for research, Need for the design of Experiments, Experiential Design Technique, plagiarism

https://youtu.be/7GrLUYC_SIo

PDFRESEARCH

### Session 24

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

https://youtu.be/4ZGa4sjJWZ0

### Session 25

Designing the methodology: Sample size determination and Power of a study

### Session 26

Designing the methodology: Report writing and presentation of data, Protocol

### Session 27

Designing the methodology: Cohorts studies, Observational studies, Experimental studies, Designing clinical trial, various phases.

### Session 28

Blocking and confounding system for Two-level factorials

### Session 29

Regression modeling: Hypothesis testing in Simple and Multiple regression models

### Session 30

Introduction to Practical components of Industrial and Clinical Trials Problems: Statistical Analysis Using Excel, SPSS

### Session 31

Introduction to Practical components of Industrial and Clinical Trials Problems: MINITAB®, DESIGN OF EXPERIMENTS

PDFMINITAB,DOE

### Session 32

Introduction to Practical components of Industrial and Clinical Trials Problems: R - Online Statistical Software’s to Industrial and Clinical trial approach

PDFR-ONLINE

### Session 33

Design and Analysis of experiments: Factorial Design: Definition, 2^2, 2^3design

### Session 34

Design and Analysis of experiments: Advantage of factorial design

### Session 35

Response Surface Methodology: Historical design, Optimization Techniques

### Session 36

Response Surface methodology: Central composite design

PDFCCD

### 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

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