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BIOSTATISTICS
AND
RESEARCH METHODOLOGY
For B.Pharma Degree Eighth Semester Programmes of ALL INDIAN UNIVERSITIES
As Per the Latest Syllabus of Pharmacy Council of India (PCI)

SURENDER SINGH DEEKSHA SHARMA

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NEW
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PCI
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As Per the Latest Syllabus of Pharmacy Council of India (PCI)
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 NEW
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Page 2
 BIOSTATISTICS AND
RESEARCH METHODOLOGY
For B.Pharma Degree Eighth Semester Programmes of ALL INDIAN UNIVERSITIES
As Per the Latest Syllabus of Pharmacy Council of India (PCI)

Dr. SURENDER SINGH

Professor
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi

DEEKSHA SHARMA
Research Scholar
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi

NEW AGE INTERNATIONAL (P) LIMITED, PUBLISHERS

LONDON • NEW DELHI • NAIROBI
•

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Copyright © 2021, New Age International (P) Ltd., Publishers
Published by New Age International (P) Ltd., Publishers
First Edition: 2021

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 Preface

From decades, research grabs a specific interest worldwide in various fields. Every year
several research studies are accomplished their objectives but will be of little attention
of the other dimension that is research methodology. It provides a great deal to the
researchers and students for the understanding of good quality of research.
This textbook dealing with the various aspects of Biostatistics and Research
Methodology. It covers syllabus of B.Pharm (Bachelor of pharmacy) course prescribed
by PCI (Pharmacy Council of India) and will assist in the accomplishment of research
studies with effective methodology and analyzing the results using appropriate
biostatistical methods for better understanding.
Regarding the scope, this book will help to understand the applications of
biostatistics in Pharmacy. In general, this subject deals with descriptive statistics,
graphics, correlation, regression, probability, sampling technique parametric and non-
parametric tests, ANOVA and introduction to design of experiment. In addition, this
also comprises the statistical software’s for analyzing the data.
The book has been written with two lucid objectives: (i) upon completion of this
course the student shall be able to understand the statistical techniques to solve statistical
problems. (ii) To know the operation of MS. Excel, SPSS, R and MINITAB and DoE.
The organization of this book is according to PCI syllabus of B. Pharm. This book
comprises of five units, consists of 17 chapters in well-arranged manner. Chapter one
covers introduction of statistics, biostatistics and frequency distribution. Chapter
two explains the measure of central tendency followed by the explanation of mean,
median, mode. Chapter three covers the measure of dispersion followed by the range
and standard deviation. Chapter four explains the correlation with the detail of Karl
Pearson’s coefficient and multiple correlations.
Chapter five presents the details of regression with curve fitting and different
type of regression. Chapter six describe the probability followed by different types of
distribution and properties. Chapter seven deals with sample population along with
the Null hypothesis, alternative hypothesis, essence of sampling, Type I error and
Type II error and standard error of mean. Chapter eight and chapter nine exclusively
explain the several parametric tests and non-parametric tests respectively. Chapter
ten is an introduction to research, presenting the need for research, need for design
(v)

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vi Biostatistics and Research Methodology

experiment, experiential design and plagiarism. Chapter eleven covers the different
type of graphs including histogram, pie chart, cubic graph, response surface plot and
counter plot graph.
In chapter twelve, sample size determination, power of study, report writing, cohort
and observation studies have been explained. Chapter thirteen gives the knowledge
of blocking and confounding system for two level factorials along with regression
modeling in chapter fourteen. Chapter fifteen has been devoted to the introduction to the
practical components of industrial and clinical trial problems. it comprises the statistical
analysis using Excel, SPSS, MINITAB, design of experiments and R online software’s.
Chapter sixteen covers the design and analysis of experiment with the detail of Factorial
design. The last chapter, seventeen deals with the response surface methodology and
provide the detail of the central composite design and optimization technique.
An attempt has been made to present a complete text for undergraduate students of
pharmacy students as per the latest Pharmacy Council of India syllabus requirement by
various Universities of India. But still, we feel that there is a much scope for improvement
and addition in this rapidly changing field. Helpful criticism and suggestions from the
readers are welcome.
Thanks are due to Mr. Saumya Gupta, Managing Director, Mr. Vipin Nautiyal and
Mr. Ajay Sharma, New Age International (P) Ltd., New Delhi for their keen interest
and attention in bringing out this book in its present form.
Further, We would like to express our gratitude and indebtedness to all our family
members for their sacrifice, affection and inspiration throughout the present work.

Surender Singh
Deeksha Sharma

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 Contents

Preface (v)

Syllabus (vii)

UNIT–I : Introduction to Statistics

1. Introduction 3–6
1.1 Statistics 3
1.2 Biostatistics 4
1.3 Frequency Distribution 4
Suggestive Questions 6
2. Measures of Central Tendency 7–18
2.1 Mean 7
2.2 Median 13
2.3 Mode 15
Suggestive Questions 18
3. Measures of Dispersion 19–22
3.1 Dispersion 19
3.2 Standard Deviation 20
3.3 Range 22
Suggestive Questions 22
4. Correlation 23–28
4.1 Definition 23
4.2 Karl Pearson’s Coefficient of Correlation 24
4.3 Pearson’s Product Moment Correlation 25
Suggestive Questions 28

(ix)
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x Biostatistics and Research Methodology

UNIT–II : Regression and Probability

5. Regression 31–35
5.1 Curve Fitting by the Method of Least Squares 31
5.2 Simple Regression 32
5.3 Fitting the Lines y = a + bx and x = a + by 32
5.4 Multiple Regressions 33
5.5 Standard Error of Regression 34
Suggestive Questions 35

6. Probability 36–39
6.1 Definition of Probability 36
6.2 Binomial Distribution 38
6.3 Poisson’s Distribution 38
Suggestive Questions 39

7. Sampling 40–53
7.1 Properties–Problems Sample 41
7.2 Collection of Data–Population, Large and Small Sample 43
7.3 Types of Data 47
7.4 Hypothesis Testing—Null Hypothesis and Alternate Hypothesis 49
7.5 The Level of Significance 51
7.6 Error-I and Error-II Type 52
7.7 Standard Error of Mean (SEM) 52
Suggestive Questions 53

8. Parametric Tests 54–65

8.1 Student’s t-Test 54
8.2 Least Significance Difference 58
8.3 Analysis of Variance (ANOVA) 59
Suggestive Questions 65

UNIT–III : Introduction to Research and Methodology

9. Non Parametric Tests 69–81
9.1 Chi-Square Test 69
9.2 Wilcoxon Signed Rank Test 74

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 Contents xi

9.3 Rank Sum Test 74

9.4 Wilcoxon-Mann-Whitney U-Test 75
9.5 Kruskal-Wallis Test 76
9.6 Friedman Test 78
Suggestive Questions 81

10. Introduction to Research 82–92

10.1 Need for Research 83
10.2 Need for Design of Experiments 86
10.3 Basic Principles of Experimental Design Technique 86
10.4 Plagiarism 90
Suggestive Questions 92

11. Graphs 93–105

11.1 Bar Diagram 100
11.2 Pie Diagram 101
11.3 Line Diagram 102
11.4 Scatter Diagram 103
11.5 Response Surface Plot and Contour Plot 104
Suggestive Questions 105

12. Designing the Methodology 106–121

12.1 Sample Size Determination 108
12.2 Power of a Study 111
12.3 Report Writing and Presentation of Data 112
12.4 Protocol 113
12.5 Designing Clinical Trial 115
12.6 Prospective Cohort Studies 118
12.7 Experimental Studies 120
Suggestive Questions 121

UNIT–IV : Modelling and Clinical Trial Problems

13. Blocking and Confounding System 125–128

13.1 Blocking System 125
13.2 Confounding System for Two Level Factorials 126
Suggestive Questions 128

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xii Biostatistics and Research Methodology

14. Regression Modeling 129–136

14.1 Hypothesis Testing in Simple Linear Regression 129
14.2 Multiple Regression Models 134
Suggestive Questions 136

15. Introduction to Practical Components of Industrial and

Clinical Trials Problems 137–144
15.1 Statistical Analysis using Excel 137
15.2 SPSS 138
15.3 Minitab 139
15.4 Design of Experiment 143
15.5 R-Online Statistical Software to Industrial and
Clinical Trial Approach 143
Suggestive Questions 144

UNIT–V : Design and Analysis of Experiments

16. Factorial Design 147–151
16.1 Factorial Design 147
16.2 2 × 2 and 2 × 3 Factor Design 148
16.3 Advantage of Factorial Design 151
Suggestive Questions 151

17. Response Surface Methodology 152–158

17.1 Central Composite Designs 154
17.2 Historical Design and Optimization Techniques 156
17.3 Optimization Techniques 157
Suggestive Questions 158

Index 159–161

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 CHAPTER 1
Introduction

1.1 STATISTICS
Statistics involves activities like planning a survey, or an experiment; collection,
summarization, and analysis of data; interpretation and presentation of results in a
convincing format; and utilising this information in taking decisions that entail least
error. Statistics tool is useful in research studies containing large volume of raw data,
to simplify and provide easy access to understanding the research. Initially the data
can be generalized in small groups that are called samples to populations. Majorly two
types of Statistics are used to analyse data:
1. Descriptive statistics
2. Inferential statistics
Descriptive statistics provides the summarization and features of specific data
which can be either a representation of the total or a sample of a population. Descriptive
statistics put apart into measures of central tendency (including mean, median,
mode) and Measures of variability (including the standard deviation and variance).
Whereas Inferential statistics are concerned with testing the statistical hypotheses and
estimation of population parameters.
Research studies or clinical trials/ surveys are used to sum up by important statistical
measures such as:
(a) Measures of central tendency: Further, the important parts of measures of central
tendency are the arithmetic average or mean, median and mode. Geometric mean and
harmonic mean are also used in some given data.
(b) Measures of dispersion: Variance and Standard deviation are the common
measures whereas mean deviation, range, Coefficient of variation/ Standard deviation
is also used as measures of dispersion.
(c) Measures of asymmetry (skewness): The most common measure of skewness is
based on mean and mode or on mean and median whereas other measures of skewness
are based on quartiles or on the methods of moments. Kurtosis is also used to measure
the frequency distribution.
(d) Measures of relationship: Karl Pearson’s coefficient of correlation and Yule’s
coefficient of association is very often used measure in case of statistics of variables and
statistics of attributes respectively. Multiple correlation coefficients, partial correlation
coefficient, regression analysis and many others are important measures used in research
studies.

3
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4 Biostatistics and Research Methodology

1.2 BIOSTATISTICS
Medicine is essentially an empirical science. It depends on observations and not on
theories. A prerequisite for any medical decision, be it for diagnosis, for treatment or for
prognosis, is that some information is available for the patient. Experience on previous
patients of that kind helps to arrive at a valid decision. Previous information and hence
medical data are necessary. All medical data are always subject to some degree of
variation. For example, decision regarding treatment regimen depends intensely on
data related to measurements such as blood glucose level, cholesterol level and blood
pressure. Normal levels of these parameters differ from person to person. Also, a
person of age 70 years with low haemoglobin level is treated differently than a person
with high haemoglobin level, or a person of age 50 years. As a result, uncertainties
are integral part of this process. In fact medicine is notorious for enormity of such
uncertainties. These easily throw any decision out of gear when proper care is not taken.
Consequently a separate discipline has grown to manage medical uncertainties. This
is called biostatistics.
The basic aim of research is to reach to a conclusion that can be extrapolated to
the future subjects. The research ought to be more systematic and more methodical so
that the results are believable. Because of this, it is all the more important in the case of
research so that uncertainties are properly managed.

1.3 FREQUENCY DISTRIBUTION

Frequency distribution is used as a statistical tool which provides a visual representation
of observations or number of occurrences (frequency) of distinct values distributed
within a given interval either in graphical (Histogram and a bar chart) or tabular format.
For example:
In Table 1.1, cholesterol level categories look like 160-179 and 180-199, possibly
indicating that there is gap of one between 179 and 180 but actually there is none as
explained earlier.
In Table 1.1, the number of women of age 20 to 29 years in different categories
of mean corpuscular haemoglobin concentration (MCHC). MCHC of 25 percent is
considered very low and a level of 35 percent very high. The categories are 25.0-26.9,
27.0-28.9, etc. Since MCHC is measured up to one decimal place, these categories are
continuous. Effectively there is no gap between 26.9 and 27.0 that means there is no
woman with MCHC level.
Table 1.1: Distribution of MCHC in 200 women of age 20-29 years.
MCHC (%) No. of Women
25.0 - 26.9 3
27.0 - 28.9 0
29.0 - 30.9 48
31.0 - 32.9 86
33.0 - 34.9 55
35.0 - 36.9 7
37.0 - 38.9 1

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 Introduction 5

Histogram: When the categories are quantitative and continuous, and the
presentation is for the number of cases in various categories as in table 1.1, the best
representation is by histogram. This uses contiguous bars as shown in figure 1.1a. The
blank space between 27 and 29 is not a gap but shows that there is no woman with
MCHC level in this category.

Fig. 1.1: (a) Histogram, (b) Polygon and (c) Curve.

Polygon: The points plotted in figure 1.1b are in the middle of the class-intervals
and vertically at a height corresponding to the number of cases in that interval. Joining
of these points gives the polygon—more fully a frequency polygon. The first point is at
zero in interval 23-25 indicating no woman with this level, and similar is the last point
Frequency Curve: Since the variable MCHC on the horizontal axis in figure 1.1c is
actually continuous, it is possible to conceive that there are 100 or more class-intervals (in
place of existing seven) of extremely small width with MCHC measured very accurately
to several decimal places and that the number of subjects is several thousand in place
of the present 200. Then there will be some cases with level between 27 and 29 also. If

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6 Biostatistics and Research Methodology

a polygon is redrawn in this situation, this will tend to take a shape of a curve. This is
called the frequency curve and depicts the long-term distribution of MCHC.

Gaussian Distribution
The frequency curve in figure 1.1c MCHC(%) data is not symmetrical. Left tail is slightly
longer than the right tail. Such a distribution of values is called left-skewed. If the
women are generally undernourished, the lower values would be quite common and
the distribution would be left-skewed.
Figure 1.2 a shows a left-skewed distribution of Hb level in under-nourished women.
If the women are well-nourished or in good health, maximum number may have Hb
around 14 g/dl, and there will be as many on the lower side as on the upper side. The
shape of the curve would be approximately symmetric as shown in figure 1.2(b).

Fig. 1.2: Distribution of under-nourished and well-nourished women by haemoglobin level.

Not only that this pattern has bilateral symmetry with peak in the middle but the
rate of decline on either side has a specific pattern. This is popularly identified as bell-
shape. This can be studied mathematically, and is known as Gaussian after the name
of the person who first noticed this shape. This is also called normal curve.

SUGGESTIVE QUESTIONS
1. How do you differentiate between descriptive statistics and inferential statistics?
2. How biostatistics plays an important role in pharmacy?
3. Write short notes on:
(a) Measures of asymmetry (skewness)
(b) Measures of relationship
(c) Charles Spearman’s coefficient of correlation (or rank correlation).
4. Write a short note on frequency distribution.

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 Get free access to e-books for 3 Months
Best Selling Textbooks in PHARMACEUTICAL SCIENCES
by
Renowned Authors from Prestigious Publisher

Compliments from to all Faculty Members

already LIVE @ Download the App to access e-books:

Indian Institute of Technology Kanpur, Uttar Pradesh

Visvesvaraya Technological University (Consortium), Belgaum, Karnataka

National Institute of Technology, Kurukshetra, Haryana

LLEGE (DEEM
CO ED
NG T
RI

O
EE

BE
NJAB ENGIN

UNI
VERSITY)

Punjab Engineering College, Chandigarh

PU

Rajiv Gandhi Proudyogiki Vishwavidyalaya (Consortium), Bhopal, Madhya Pradesh

Bennett University (Times of India Group), Greater Noida, Uttar Pradesh

Jamia Millia Islamia - A Central University, New Delhi Username: PHARMACY2021

.... & MANY OTHER REPUTED UNIVERSITIES Password: PHARMACY2021

CONTACT US TO KEEP LEARNING!

Ms. Atika Khanna





































Mr. Ranjan Roy

































Mr. Manish Gupta
9999709935
9315905298





































9315905295
BIOSTATISTICS AND RESEARCH METHODOLOGY

Click Here to Buy the Book Online MRP: 299.00

ISBN: 978-93-89802-38-2
Committed to Educate the Nation
NEW AGE INTERNATIONAL (P) LIMITED, PUBLISHERS
LONDON • NEW DELHI • NAIROBI
•

IN INDIA
9 789 389 80 238 2