PES College of Pharmacy, Bengaluru 50 IV.

Pharm D & I PB Programme

BIOSTATISTICS AND RESEARCH METHODOLOGY (THEORY)

NAME OF THE FACULTY: Mr. Biswa Ranjan Patra

NO. OF HOURS: 50
1. Scope and objectives: The objective of the clinical development program
for a new drug is to find out whether the drug can be shown to be simultaneously
safe and effective. Each clinical study needs to be designed and conducted
carefully in accordance to standard guidelines and principles. The role of statistics
in clinical trials design, analysis and reporting is essential. We look in to various
statistical aspects of designing an appropriate clinical study, hypothesis of a study
and computing the appropriate number of subjects to be recruited in the trial,
organizing various aspects of graphical display of data.
2. After completion of the subject, the student will be able to know:
 Select appropriate clinical study design for clinical studies.
 Write the components of protocol used in clinical studies.
 Statistically calculate the sample size required for the clinical studies.
 Display the outcome of the clinical studies by selecting appropriate graphs.
 Present, organize, and summarize the collected clinical data by descriptive
statistics.
 Ability to generalize the results from the sample study to the appropriate
population by using inferential statistics.
 Know the applications of computer in hospital and community pharmacy.
 Handle the smooth operation of hospital pharmacy by inventory control
techniques.

 Statistically analyze and derive the results form epidemiological studies.

CLASS PORTION TO BE COVERED REFERENCE BOOKS PAGE NOS
No.
1 2 3
4
RESEARCH METHODOLOGY 10 HRS
01 Types of clinical study designs 311 --- ----
02 a) Case studies 316 --- ----
03-04 b) Observational studies 318 ---- ----
05 c) Interventional studies 325 --- ----
06-07 Designing the methodology 350-367 --- ----
08-09 Sample size determination and ----
151-172 89-94
power of a study
10 Report writing and presentation of ----
170 ---
data

BIOSTATISTICS 06 HRS.
11 Introduction 1-3 01-03 ----
12 Types of data distribution 04-09 03-06 ----
13-14 Measures of central tendency 12-15 10-15 ----
15-16 Measures of spread of data 16-21 16-20 ----

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PES College of Pharmacy, Bengaluru 50 IV.Pharm D & I PB Programme

DATA GRAPHICS 06 HRS

17 Construction and labeling of
33 --- ----
graphs
18-19 Histogram 32-36 --- ----
20 Pie charts 36-39 --- ----
21 Scatter plots 40-41 --- ----
22 Semi logarithmic plots 42-43 --- ----

BASICS OF TESTING HYPOTHESIS 12 HRS

23 Null hypothesis 104-111 67-68 ----
24 Level of Significance 112-126 69-87 ----
25 Confidence Intervals 96-103 49-61 ----
26 P value 161-162 83-86 ----
27-28 Level of significance (parametric 117-126,
data) Studentd t test, chisquare 141-146 133-144, ----
test, 210-219
29 Analysis of variance (ANOVA) 215-256 146-167 ----
30-31 Level of significance (Non
parametric data) Sign test,
464-500 224-242 ----
wilcoxan signed rank test,wilcoxan
rank sum test, kruskal-wallis test
32-33 Linear regression and correlation 173-214 170-192 ----
34 Introduction to statistical software 599 ----

STATISTICAL METHODS IN EPIDEMIOLOGY 06 HRS

35-38 Incidence and prevalence 506 ---- ----
39 Relative risk

510 --- ----

40 Attributable risk 518 --- ----

COMPUTER APPLOICATIONS IN PHARMACY 10 HRS

41-45 Computer system in hospital 564 --- ----
Pharmacy
46-49 Computer in community Pharmacy 571 --- ----
50 Drug information retrieval and 573 --- ----
storage

REFERENCE BOOKS FOR THEORY

1. Pharmaceutical Statistics Practical and Clinical application, Sanford Bolton 3 rd
edition, publisher Marcel Dekker Inc. New work.
2. Essential statistics for the pharmaceutical sciences, by Philip Rowe, wiley
publication.
3. Drug Information: A guide for Pharmacists, Patrick M Malone, Karen L Kier, John
E Stanovich, 3rd edition, McGraw Hill Publications 2006.

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PES College of Pharmacy, Bengaluru 50 IV.Pharm D & I PB Programme

QUESTION BANK
Chapter 1: Research Methodology
LONG ESSAY
1. What is sample size? Discuss briefly about determination of sample size for
simple comparative experiments with suitable examples.
2. Write notes on a) randomization, b) objectives c) direct and surrogate end
point in Clinical study. (5+2+3)
3. Discuss briefly about designing the methodology. B) Describe how a sample
size is determined for simple comparative experiments.
4. Discuss briefly about determination of sample size for simple comparative
experiments and for confidence interval of specific width.
5. DISCUSS in detail about various clinical studies designs.
SHORT ESSAY
6. Give a detailed account of sample size determination.
7. Describe the case study method.
8. Explain Report writing and Presentation of data.
9. Write short notes on case studies and observational studies.
10. Explain Power of a study.
11. Describe various clinical study designs in detail? Write about the importance
of Biostatistics?
12. What are case studies, Explain.
13. Discuss different types of observational clinical studies in detail.
14. Explain in detail about cross-over and parallel clinical study design
15. Write a note on randomization in clinical study.
SHORT ANSWER
16. Define blinding in clinical study.
17. Define bias in clinical study.
18. Define power of a study?
19. Relationship between sample size and power of the test.
20. Writeshortnoteon:StratifiedRandomSampling
21. Write notes of interventional studies.
22. What is case study
23. Define Cohort
24. What is sample size
25. Classification of clinical study design.
26. What is carry over effect?
27. Define cross sectional study.

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PES College of Pharmacy, Bengaluru 50 IV.Pharm D & I PB Programme

28. Define surrogate & direct end point.

29. Importance of control group in clinical study.
30. Inclusion and Exclusion Criteria in clinical study.
Chapter 2: Biostatistics
LONG ESSAY
1. Describe the various types of measures of dispersion and their significance.
2. What do you understand by measures of central tendency? Describe the main
types of measures and their characters.
3. Explain with the help of a suitable example, different measures of central
tendency. Give reasons why they are called as measures of central tendency.
SHORT ESSAY

4. Write short notes on standard deviation and variance

5. Explain median and mode
6. Describe variance and standard error of mean with suitable example.
7. Describe how Mean is the most appropriate measure of centrality with
suitable example?
SHORT ANSWER
8. Difference between S.D and SEM.
9. Difference between ordinal and ratio scale of quantitative variables.
10. Define normal distribution of data?
11. Define coefficient of variation.
12. Define median and mode.
13. Quantitative and Qualitative variables.
14. Define descriptive and inferential statistics.
15. Define discrete and continuous variables.
16. When is the mean the best measure of central tendency?
17. When is the median the best measure of central tendency?
18. When is the mode the best measure of central tendency?
Chapter 3: Data Graphics

LONG ESSAY
1. How do you think the Histograms, scatter plots, and semi-logarithmic plots
are useful in presenting the data?
2. Describe the construction of different types of graphical representation of
statistical data with SUITABLE examples.
3. Write short note on Five of the following
a) Histogram

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PES College of Pharmacy, Bengaluru 50 IV.Pharm D & I PB Programme

b) Pie chart
c) Semi-logarithmic plots

SHORT ESSAY
4. Discuss the general rules for constructing and labeling a graph? b) Describe
the construction of a semi-logarithmic graph with an example?
5. Semi logarithmic plot.
6. What are the disadvantages of pie chart?
SHORT ANSWER
7. Define Histogram
8. Advantages and disadvantages Pie charts.
9. Define scatterplots
10. Define semi logarithmic plots.
Chapter 4: Basics of testing of hypothesis
LONG ESSAY:
1. What is hypothesis? What are different types of hypothesis? Explain how you
formulate the hypothesis with a suitable illustration.
2. Discuss various parametric tests used to determine level of significance of a
clinical study.
3. Discuss various parametric tests used to determine level of significance of a
clinical study.
4. Discuss various steps involved in testing the significance of single mean and
difference between two means (independent samples) in small samples using
student‘t’ test.
5. Explain Null hypothesis, level of significance, power of test, P value.
6. SHORT ESSAY
7. Write a note on null and alternate hypothesis
8. Explain wilcoxan’s signed rank test and Sign test
9. Explain statistical software of SPSS, Epi info.
10.Note on Correlation and Regression and their applications
11. Explain various student t tests with suitable examples.
12. Explain Wilcoxan signed rank test and Mann Whitney U test.
13.Explain the uses of chi-square test giving suitable examples
14. Describe analysis of variance by stating related assumptions. Explain why
students t-test can not be applied where ANOVA has to be applied.
15. What is ANOVA. Explain the method of one way ANOVA.

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PES College of Pharmacy, Bengaluru 50 IV.Pharm D & I PB Programme

16. What is underlying assumptions of one way ANOVA? If these assumptions are
not fulfilled which alternative non-parametric test do you suggest.
17. What is correlation? Name different types of correlation. Which are the
different measures of correlation?
18. What are the assumptions under which chi-square test can be applied to
analyze data. For what type of data chi-square test is applied.
19. Explain the need for testing of hypothesis in pharmaceutical research.
20. What is linear regression? How is it useful in pharmaceutical sciences?
21. Explain chi square test and write the application of student t test.
SHORT ANSWER
22.Type I and Type II errors.
23. One tailed and two tailed tests.
24. Mann Whitney U tests.
25. Explain one way analysis of variance.
26. Define Regression. Explain types of regression.
27. Types of correlation.
28. Level of significance.
29. Paired t – test.
30. Wilcoxon rank sum test.
31. Degree of freedom.
32. Student’s t-test.
33. Difference between statistics and parameter.
34. Confidence intervals.
35. Difference between statistics and parameter
36. Difference between ANOVA and student t test.
37. Comparison of means between two distinct/independent groups which
parametric and non parametric test can be used in inferential statistics?
38. Comparison of two quantitative measurements taken from the same individual
which parametric and non parametric test can be used in inferential statistics?
39. Comparison of means between three or more distinct/independent groups
which parametric and non parametric test can be used in inferential statistics?
40. Define level of significance.
Chapter 4: Statistical methods in epidemiology
LONG ESSAY:
1. Define Epidemiology. Explain in detail various study designs used in
epidemiology.

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PES College of Pharmacy, Bengaluru 50 IV.Pharm D & I PB Programme

SHORT ESSAY
2. Write notes on Incidence and prevalence.
3. Write notes on relative and attributed risk.

Chapter 5: Computer applications in pharmacy:

LONG ESSAY:

1. Explain the role of computers in Patient medication profiles and Inventory

control.
2. Elucidate the computer use in hospital pharmacy.
SHORT ESSAY
3. Explain the uses of computers in drug information retrieval and storage.
4. Computer medication order entry.
5. Explain Drug information retrival and storage.
6. Write the use of computers for pharmaceutical care in community
Pharmacy.
7. Explain Patient medication profiles and Inventory control.
8. Computerizing the prescription dispensing process.
9. Write out the patient record database management.
10.Advantages of Computerized Medication Order Entry.
11.Uses of Computers in Pharmaceutical care.

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