Rajiv Gandhi University of Health Sciences, Karnataka

VIII Semester B. Pharm Degree Examination – 11-Nov-2021

Time: Three Hours Max. Marks: 75 Marks

BIOSTATISTICS AND RESEARCH METHODOLOGY

Q.P. CODE: 5033
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory
LONG ESSAYS 2 x 10 = 20 Marks
1. Explain the measures of central tendency.
Calculate the mean and standard deviation for the following data on systolic BP of volunteers –
Systolic BP (mmHg) 91-100 101-110 111-120 121-130 131-140 141-150
Frequency 08 14 20 26 24 18
OR
Explain different types of hypothesis. Explain type I and type II errors, level of significance, P
value.

2. Explain the different phases of clinical trials.

SHORT ESSAYS 7 x 5 = 35 Marks
3. Explain types of correlation and correlation coefficient. Give suitable examples.
OR
Define probability and explain its significance in statistical inference with examples.

4. What are measures of dispersion? Explain.

OR
Explain ANOVA and its applications.

5. Discuss different methods of sampling.

6. Explain the graphical methods of representing quantitative data.
7. Discuss the applications of EXCEL and SPSS programmes in statistical analysis.
8. What are non-parametric tests? Explain chi square test-Goodness of fit test.
9. Explain the types and advantages of factorial design in formulation development.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Multiple regressions.
11. One tailed and Two tailed tests.
12. Pharmaceutical examples for optimization techniques.
13. Degrees of freedom.
14. Standard error of mean and its significance.
15. Two methods of sample size calculation in research study.
16. Examples of application of regression models in stability testing.
17. Wilcox on Rank Sum test.
18. Normal distribution of data.
19. Types of Observational study designs.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VIII Semester B. Pharm Degree Examination – 14-Jun-2022

Time: Three Hours Max. Marks: 75 Marks

BIOSTATISTICS AND RESEARCH METHODOLOGY

Q.P. CODE: 5033
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Describe briefly the different interventional study designs.
OR
Explain the hypothesis testing of non-parametric data.
2. Describe the various types of measures of dispersion and their significance.
SHORT ESSAYS 7 x 5 = 35 Marks
3. Explain report writing in research methodology.
OR
Explain regression analysis.
4. Describe variance and standard error of mean with suitable example.
OR
What are the underlying assumptions of one way ANOVA? Explain under what circumstances
ANOVA is the most preferred type of statistical data analysis?

5. Discuss the general rules for constructing and labeling a graph? Describe the construction of
a semi-logarithmic graph with an example?
6. Compare and contrast Nonparametric and Parametric data.
7. Explain student t test and its types

8. Explain Fractional Factorial Design.

9. Role of QbD in Pharmaceutical Development.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Define bias in clinical study.
11. Role of sample size in calculation of confidence interval.
12. Characteristics of normal distribution.
13. Advantages and disadvantages Pie charts.
14. Explain: Range, Inter quartile range and Variance.
15. Standard Error of Mean.
16. One tailed and two tailed tests.
17. Control Space.
18. Inclusion and exclusion criteria.
19. Define histogram.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VIII Semester B. Pharm Degree Examination – 16-Nov-2022

Time: Three Hours Max. Marks: 75 Marks

BIOSTATISTICS AND RESEARCH METHODOLOGY

Q.P. CODE: 5033
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Discuss briefly about determination of sample size for simple comparative experiments and
for confidence interval of specific width.
OR
Explain the hypothesis testing of non-parametric data.

2. How is QbD based product development better. Explain the steps in involved in it.
SHORT ESSAYS 7 x 5 = 35 Marks
3. Classify different types of data. Explain any three measures of dispersion with examples.
OR
Classify and list the tests used for hypothesis testing of parametric data.
4. Classify and explain different types of t- tests.
OR
Explain Pearson’s correlation and Spearmann’s correlation.
5. Explain the phases of Clinical trials.
6. Explain in detail about cross-over and parallel clinical study design.
7. Explain about homogeneity of variance, homoscedasticity, ,  and post parametric testing.
8. What are Mixture Designs? List their applications.
9. Explain linear regression. How is it applied for pharmaceutical sciences?

SHORT ANSWERS 10 x 2 = 20 Marks

10. Define discrete and continuous variables.
11. Pie charts.
12. What is Bias ?
13. What is Control Space
14. Difference between ANOVA and student t test.
15. Define and explain probability.
16. Define α and β error.
17. Degree of freedom.
18. Classify observational and experimental studies.
19. What is interventional study?

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 Rajiv Gandhi University of Health Sciences, Karnataka
VIII Semester B. Pharm Degree Examination – 30-May-2023

Time: Three Hours Max. Marks: 75 Marks

BIOSTATISTICS AND RESEARCH METHODOLOGY

Q.P. CODE: 5033
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Describe the different measures of central tendency. Calculate mean and standard
deviation for the given data on mid arm circumference(cm) of 16 children –
14, 12, 13, 10, 11, 13, 14, 12, 12, 11, 10, 13, 12, 11, 10, 14.
OR
Explain types of observational study designs.

2. Explain with suitable examples regression analysis and standard error of regression.
SHORT ESSAYS 7 x 5 = 35 Marks
3. Explain type I and type II errors.
OR
Discuss the methods of sample size calculation in comparative studies.
4. Explain Karl Pearson’s coefficient of correlation with examples.
OR
Explain chi square test for association.
5. Discuss the applications of SPSS and SAS in research study.
6. Explain one way ANOVA and the assumptions in one way ANOVA.
7. Briefly describe the different distribution patterns of data.
8. Discuss- Histogram, Bar diagram.
9. Explain phases of clinical trial.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Degrees of freedom.
11. 22 and 23 designs.
12. Power of a study.
13. Probability.
14. Applications of student ‘t’ test.
15. Standard error of mean.
16. One tailed and Two tailed tests.
17. Applications of non-parametric tests.
18. Confidence interval.
19. Pharmaceutical examples of optimization techniques.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VIII Semester B. Pharm Degree Examination – 03-Nov-2023

Time: Three Hours Max. Marks: 75 Marks

BIOSTATISTICS AND RESEARCH METHODOLOGY

Q.P. CODE: 5033
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory

LONG ESSAYS 2 x 10 = 20 Marks

1. Explain the various phases of clinical trials.
OR
Explain regression analysis and its applications in stability testing of pharmaceuticals.
2. Explain the measures of dispersion. Calculate mean, variance and standard deviation for the
given data:-
Height(cm) 135-140 141-145 146-150 151-155 156-160 161-165 166-170
Frequency 08 12 18 22 20 14 10.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Define and explain correlation with examples.
OR
Explain student ‘t’ test and its applications.
4. Explain types of observational study designs.
OR
Explain ANOVA and its significance.
5. Discuss null hypothesis, type I and type II errors.
6. Explain the application of factorial design in pharmaceutical product development.
7. Explain with examples- Histogram, Pie chart.
8. Describe the sampling techniques in research study.
9. Discuss Wilcoxon Rank Sum test and Mann Whitney U test.

SHORT ANSWERS 10 x 2 = 20 Marks

10. Chi square test.
11. Power of a study.
12. Confidence interval.
13. Probability.
14. Applications of SAS.
15. Standard error of mean.
16. When is median more important than mean as a measure of central tendency.
17. Optimization techniques.
18. Report writing in research study.
19. Features of normal distribution pattern.

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 Rajiv Gandhi University of Health Sciences, Karnataka
VIII Semester B. Pharm Degree Examination – 29-May-2024

Time: Three Hours Max. Marks: 75 Marks

BIOSTATISTICS AND RESEARCH METHODOLOGY

Q.P. CODE: 5033
Your answers should be specific to the questions asked
Draw neat labeled diagrams wherever necessary
All the Questions are compulsory
LONG ESSAYS 2 x 10 = 20 Marks
1. Discuss the protocol for an experimental study design.
OR
Explain ‘t’ test. Find if there is statistical significance in the serum digoxin level in the given
data:- Critical value= 2.31(p< 0.05)

Serum digoxin
1 2 3 4 5 6 7 8 9
level(mcg/ml)
After4 hrs 1.0 0.9 1.0 1.3 1.0 1.3 0.9 1.1 1.0
After 8 hrs 1.0 0.7 1.0 1.2 0.9 1.3 0.8 1.0 1.0

2. What are measures of dispersion? Explain their significance with suitable examples.

SHORT ESSAYS 7 x 5 = 35 Marks

3. Explain correlation, types of correlation and its applications.
OR
Explain null hypothesis, type I and type II errors.

4. Discuss with examples measures of central tendency.

OR
Discuss the sampling methods in research study.

5. Explain probability and its significance in statistical analysis.

6. Explain regression analysis to assess the influence of independent variable on continuous
variable.
7. Explain the hypothesis testing using one way of ANOVA.
8. Describe the various graphical methods of representing quantitative data.
9. Explain cohort study.
SHORT ANSWERS 10 x 2 = 20 Marks
10. Sample size calculation for confidence interval.
11. Power of a study.
12. Pharmaceutical examples for data analysis using SPSS.
13. Factorial design.
14. Degrees of freedom.
15. Report writing in research study.
16. Assumptions in chi square test.
17. Confidence interval.
18. Characteristics of Normal distribution data.
19. Applications of nonparametric tests.
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