**BP801T. BIOSTATISITCS 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’s, 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
statistical problems

• Appreciate statistical techniques in solving the problems.

**Course
content:**

**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

**Probability:** Definition
of probability, Binomial distribution, Normal distribution, Poisson’s distribution,
properties - problems

Sample, Population, large sample, small sample, Null
hypothesis, alternative hypothesis, sampling, essence of sampling, types of
sampling, Error-I type, Error-II t ype, 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**

**Blocking and
confounding system for Two-level factorials**

**Regression modeling:**
Hypothesis testing in Simple and Multiple regressionmodels 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, 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

**Notes Coming Soon...................**

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