Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. – SEMESTER VIII EXAMINATION – WINTER-2022
Subject Code:BP801TT Date:09/01/2023
Subject Name: Biostatistics and Research Methodology
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain correlation, type of correlation and its application in research. 06
(b) Explain the following terms: 05
a) Biostatistics
b) Arithmetic mean
c) Dispersion
d) Frequency distribution
e) Range
(c) The weight of 10 tablets is given below (in mg). Calculate the mean, median 05
and mode.
520, 525, 530, 510, 525, 535, 540, 510, 515, 525
Q.2 (a) Write a note on probability sampling techniques. 06
(b) What are probabilities? Explain normal distribution. 05
(c) Define Standard deviation. Calculate the standard deviation of following 05
sample data:
10, 12, 14, 16, 20, 24, 28, 30
Q.3 (a) What is regression analysis? Explain in detail least square method for 06
regression analysis.
(b) Describe the following: 05
a) Standard error of mean
b) Quota sampling
(c) Define t-test and explain different type of t-tests. 05
Q.4 (a) What are parametic tests? Explain in detail about the one way ANOVA. 06
(b) Explain Wilcoxon Rank sum test and Friedman test. 05
(c) Discuss Histogram and Pie chart. 05
Q.5 (a) What is research? Explain in detail experimental design techniques. 06
(b) Write a short note on research report. 05
(c) Explain in detail cohorts and experimental studies. 05
Q. 6 (a) Write a note on blocking and confounding for two level factorial design. 06
(b) Explain the central composite design. 05
(c) Write a note on hypothesis testing in simple regression model. 05
Q.7 (a) Define factorial design. Write a note on 23 factorial design. 06
(b) Write the importance of SPSS and MIN ITAB software in clinical trials. 05
(c) Explain the following: 05
a) Null hypothesis and alternative hypothesis
b) Type – I error and Type – II error
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER–8 • EXAMINATION – WINTER -2022
Subject Code: BP802TT Date:26/12/2022
Subject Name: Social and Preventive Pharmacy
Time: 02:30PM to 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Highlight brief guidelines of Swachh Bharat Mission (SBM) / Total Sanitation 06
Campaign (TSC).
(b) Discuss pre-pathogenesis phase & pathogenesis phase involved in natural 05
history of disease.
(c) Explain sign and symptoms of SARS. Discuss the measures to prevent and 05
control the SARS disease.
Q.2 (a) What is Malnutrition? What are the causes of Malnutrition? How do you 06
prevent Malnutrition?
(b) Discuss the impact of urbanization on health and disease. 05
(c) Explain the symptoms of Vitamin A deficiency and Vitamin B12 deficiency. 05
Q.3 (a) Explain National Drug Policy for Malaria (2013). Also discuss the measures to 06
prevent and control the Malaria.
(b) Write a brief note on “National tobacco control program” 05
(c) What is Balanced diet? Discuss the concept & importance of healthy balanced 05
diet plan.
Q.4 (a) Discuss the causes of Drug addiction. Discuss the measures to prevent and 06
control the Drug addiction.
(b) Explain the structure, role and function of WHO in Indian national program. 05
(c) Discuss the structure of health care system and explain the functions of PHC. 05
Q.5 (a) Describe the objectives, functioning, key strategies and outcome of NACP. 06
Also discuss package of services provided under NACP-IV.
(b) Comment on “National Strategic Plan 2017-2025 for TB Elimination in India” 05
(c) Discuss Pulse polio program in detail. 05
Q. 6 (a) Explain sign and symptoms of Dengue. Discuss the measures to prevent and 06
control the Dengue.
(b) Discuss Salient features of the National Leprosy Eradication Program. Explain 05
Activities under NLEP.
(c) Enlist maternal health program and Discuss major goals with important 05
considerations/justifications of MCH intervention program (MCH care).
Q.7 (a) Discuss Universal immunization program in detail with IAP recommendations. 06
(b) Explain the main causes of blindness. Discuss goals and objectives of National 05
Programme for Control of Blindness and Visual Impairment (NPCB&VI).
(c) Discuss types of Diabetes mellitus. Explain prevention measures using 05
Self-care and Insulin therapy to control Diabetes.
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER–VIII • EXAMINATION – WINTER -2022
Subject Code:BP803TT Date:28/12/2022
Subject Name: Pharma Marketing Management
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Discuss any three emerging concepts in marketing. 06
(b) Explain the pharmaceutical marketing channels selection process. 05
(c) What is a Product? Explain Product Mix and Product Line. 05
Q.2 (a) Discuss product portfolio analysis and its significance. 06
(b) Provide an overview of Drug Price Control Order 05
(c) Discuss the trends in OTC drug marketing in India. 05
Q.3 (a) Marketing research helps to reduce the uncertainty surrounding the decisions to 06
be made – Justify the statement.
(b) Write a note on factors influencing prescribing decisions of physicians. 05
(c) Draw a labelled diagram of physical distribution management. 05
Q.4 (a) Discuss the objective and impotance of Pharma Marketing Management. 06
(b) Discuss – How pharma brands can amplify sustainable packaging? 05
(c) Discuss the role of public relations in product promotion. 05
Q.5 (a) Analyze the consumer buying behavior and industrial buying behavior. 06
(b) Selling transforms the goods into money, but marketing is the method of 05
serving and satisfying customer needs (True/false). Justify your answer.
(c) Discuss the socio-psychological characteristics of the consumer. 05
Q. 6 (a) Write a detail note on professional sales representative. 06
(b) Explain product management in pharmaceutical industry. 05
(c) Discuss the role National Pharmaceutical Pricing Authority. 05
Q.7 (a) Discuss four types of market segmentation. 06
(b) Write a note on pharma product lifecycle management. 05
(c) Discuss the factors influencing patient choice of community pharmacy. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph- SEMESTER–VIII • EXAMINATION – WINTER -2022
Subject Code: BP804TT Date: 28/12/2022
Subject Name: Pharmaceutical Regulatory Science
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain generic drug product development in detail. 06
(b) Write a note on clinical studies. 05
(c) Explain in brief ANDA. 05
Q.2 (a) Give overview of regulatory authorities of United States. 06
(b) Discuss in detail about IND. 05
(c) Briefly discuss CTD and eCTD. 05
Q.3 (a) Discuss Procedure for export of pharmaceutical products. 06
(b) Write a note on ACTD 05
(c) Discuss in brief DMF. 05
Q.4 (a) Discuss the procedure to develop clinical trial protocols. 06
(b) Give overview of regulatory authorities of Japan. 05
(c) Write a note on IRB. 05
Q.5 (a) Write about Informed consent process. 06
(b) Discuss about Purple book. 05
(c) Write a note on Code of Federal Regulatory. 05
Q. 6 (a) What is Orange book? Explain. 06
(b) Discuss about GCP obligations of Investigators, sponsors & Monitors 05
(c) Explain Pharmacovigilance. 05
Q.7 (a) Discuss on TGA. 06
(b) Write a note on NDA. 05
(c) Explain in brief pre-clinical studies. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph – SEMESTER– VIII • EXAMINATION – WINTER -2022
Subject Code:BP805TT Date: 23/12/2022
Subject Name: Pharmacovigilance
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Give the anatomical, therapeutic and chemical classification of drug. 06
(b) Discuss the management of ADR. 05
(c) Write a short note on pre clinical phase. 05
Q.2 (a) Write a short note on Pharmacovigilance Program of India (PvPI). 06
(b) Discuss the post approval phase (PMS) 05
(c) What is the importance of effective communication in Pharmacovigilance? 05
Q.3 (a) Give the definition and classification of ADRs with examples. 06
(b) Write a short note on cross sectional studies. 05
(c) Discuss the drug safety evaluation in pregnancy and lactation. 05
Q.4 (a) Discuss the international classification of diseases. 06
(b) Enlist the different types of methods for causality assessment and explain the 05
Naranjo Scale.
(c) Write a short note on “Schedule Y”. 05
Q.5 (a) Discuss the Vaccine Pharmacovigilance in detail. 06
(b) Discuss the importance of safety monitoring of medicine. 05
(c) Write a short note on WHO drug dictionary. 05
Q. 6 (a) Discuss the organization and objectives of ICH. 06
(b) Write a short note on Contract research organizations (CROs). 05
(c) Write a role of Good clinical practice in Pharmacovigilance studies. 05
Q.7 (a) Write a note about genetics related ADR with example. 06
(b) Discuss the specialized resources for ADRs. 05
(c) Explain about adverse events following immunization. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. SEMESTERVIII • EXAMINATION – WINTER -2022
Subject Code:BP806TT Date:23/12/2022
Subject Name: Quality Control and Standardization of Herbals
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain Physical evaluation for the quality control of herbal drugs. 06
(b) Describe HPTLC techniques in the standardization of herbal products. 05
(c) Discuss WHO Guidelines on GACP for Medicinal Plants. 05
Q.2 (a) Discuss the WHO Guidelines on cGMP of Herbal drugs. 06
(b) What is stability testing? Explain the different methods for stability testing of 05
herbal drugs in detail.
(c) Explain the WHO guidelines on safety monitoring of herbal medicines in 05
pharmacovigilance systems.
Q.3 (a) Explain the role of markers in the standardization of herbal products. 06
(b) Write a note on GLP in the traditional system of medicine. 05
(c) Describe the pharmacological and toxicological evaluation of herbal drugs. 05
Q.4 (a) Discuss ICH guidelines for quality control of herbal drugs. 06
(b) Explain in brief about good agriculture practice of herbal drugs. 05
(c) Write a note on the document preparation for new drug applications. 05
Q.5 (a) Write a note on the document preparation for export registration. 06
(b) Compare and contrast between Ayurvedic and herbal pharmacopeia. 05
(c) Explain the research Guidelines for Evaluating the Safety and Efficacy of 05
Herbal Medicines in Brief.
Q. 6 (a) Define: standardization, Shelf life, swelling index, chromatographic 06
fingerprinting, Pesticide residue, Ash Value.
(b) Write the chemical tests for identification of secondary plant metabolite. 05
(c) Discuss EU guidelines for quality control of herbal drugs. 05
Q.7 (a) Write a note on the Microscopic evaluation of crude drugs. 06
(b) Describe TLC and HPLC techniques in the standardization of herbal products. 05
(c) Discuss regulatory requirements of herbal medicines in India. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM – SEMESTER – VIII • EXAMINATION – WINTER -2022
Subject Code: BP808TT Date: 28/12/2022
Subject Name: Cell and Molecular Biology
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain fluid mosaic model. 06
(b) How denaturation of proteins occur? How does it affect various properties of 05
proteins?
(c) Define vectors. Describe the various cloning vehicles for vectors. 05
Q.2 (a) Describe in detail mechanism of transcription and translation process for DNA 06
synthesis.
(b) Define below terms: 05
a) Cell
b) Chromosomes
c) Mitosis
d) Endoplasmic reticulum
e) Nucleus
(c) What is recombinant DNA technology? Give the basic principles of 05
recombinant DNA technology and give appropriate examples of
pharmaceutical products of recombinant DNA technology.
Q.3 (a) Write a note on genome mapping. 06
(b) Biomedical importance of proteins. Give general properties of protens. 05
(c) Explain in detail structure organization of proteins. 05
Q.4 (a) Define carbohydrates. Explain TCA cycle with labled diagram. 06
(b) Give the difference between cilia and flagella. 05
(c) Classify proteins. Describe briefly peptides. 05
Q.5 (a) Write a note on DNA structure. 06
(b) Describe in detail transcriptional regulation. 05
(c) What is dominance? Explain its various types. 05
Q. 6 (a) Describe in detail meiosis. 06
(b) Define photosynthesis. Give description of photoreduction in oxygen 05
phototrophs & significance of photosynthesis.
(c) Describe in detail protein targeting. 05
Q.7 (a) What is peptide bond? Describe biologically important peptides. 06
(b) Describe genetic code. Give salient features of the genetic code. 05
(c) Briefly describe the molecular events for regulation of G1/S transition phase 05
and pathways of apoptosis.
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph- SEMESTER–VIII • EXAMINATION – WINTER -2022
Subject Code: BP809TT Date:23/12/2022
Subject Name: Cosmetic Science
Time: 02:30pm to 05:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain cosmeceutical in detail. 06
(b) Write a note on basic structure and function of skin. 05
(c) Explain in brief common problem associated with teeth and gums. 05
Q.2 (a) Give overview of formulation and building blocks of oral care products. 06
(b) Write a note on application of skin care products in formulation of 05
cosmecuticals.
(c) Discuss in brief actives & mechanism of action of deodorants. 05
Q.3 (a) Discuss classification of sunscreens and SPF. 06
(b) Write about role of henna and amla in hair care products. 05
(c) Discuss BIS specification and analytical methods for shampoo 05
Q.4 (a) Write details on principles of sebumeter. 06
(b) Discuss the procedure for measurement of TEWL. 05
(c) Write a note on hair tensile strength evaluation. 05
Q.5 (a) Explain the term comedogenic. 06
(b) Discuss about dandruff, Hair fall causes. 05
(c) Write a note on cosmetic problem associated with skin. 05
Q. 6 (a) Explain formulation and building blocks of hair conditioner. 06
(b) Discuss about formulation of toothpaste for bleeding gums 05
(c) Write about chemistry and formulation of Para-phylene diamine based hair dye. 05
Q.7 (a) Discuss on hair growth cycle. 06
(b) Write a note on cosmetic excipients. 05
(c) Explain in brief formulation of anti-dandruff shampoo. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM – SEMESTER–VIII • EXAMINATION – WINTER-2022
Subject Code:BP810TT Date: 23/12/2022
Subject Name: Experimental Pharmacology
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Write a note on: CPCSEA guidelines for maintenance, breeding and conduct of 06
experiments on laboratory animals.
(b) Discuss the principle and use of cook’s pole apparatus and analgesiometer. 05
(c) Enlist various methods for evaluation of local anesthetic agents. Explain any 05
one.
Q.2 (a) Write a brief note on routes of drug administration and euthanasia techniques 06
used for experimental animals.
(b) Write briefly in-vivo methods to evaluate anti-asthmatic drugs. 05
(c) Enumerate Antihyperlipidemic evaluation methods. Describe any one in detail. 05
Q.3 (a) Enlist in-vivo and in-vitro methods for evaluating anti- inflammatory activity. 06
And explain the method in which plethysmometer is used.
(b) Write principle and evaluation parameters for: 05
1. Rota Rod apparatus 2. Combined Open field test
(c) Write a note on screening models of Anti hypertensives. 05
Q.4 (a) Enlist the different models for evaluation of Antiulcer activity. Describe any 06
one in detail.
(b) Enlist various models for evaluation of antiparkinson activity. Explain MPTP 05
model in detail.
(c) Enlist different methods for screening of diuretic activity. Write a note on 05
metabolic cages.
Q.5 (a) Enlist various methods for evaluation of antiepileptic activity. Explain MES 06
and PTZ methods in detail.
(b) Enlist various methods for induction of diabetes in experimental animals. 05
Explain STZ induced diabetes in rats in brief.
(c) Write a note on: Graphical representation 05
Q. 6 (a) Write a note on evaluation methods for Parasympathomimetics. 06
(b) Explain different vitro models for screening of anticancer activity. 05
(c) Write a note on Lagendorff heart preparation. 05
Q.7 (a) Write a brief note on: Review of Literature and Hypothesis. 06
(b) Enlist various models for evaluation of antiarrythmic activity. Explain any one 05
model in detail.
(c) Write a note on screening methods for anti-pyretic activity. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM- SEMESTER VIII – • EXAMINATION – WINTER -2022
Subject Code:BP811TT Date: 28/12/2022
Subject Name: Advanced Instrumentation Techniques
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Explain in detail chemical ionization source used in mass spectrometer. 06
(b) Describe the rules for fragmentation of molecules in MS with suitable 05
examples.
(c) Draw a block diagram of MS. Discuss different detectors used in MS 05
Q.2 (a) Discuss important factors in sample preparation and handling in DTA 06
(b) Discuss the principle, instrumentation and application of DSC 05
(c) Draw the block diagram of TGA. Explain the factor affecting TGA curve 05
Q.3 (a) Discuss instrumentation and applications of X-ray powder diffraction technique 06
(b) Write a note on HPTLC/MS 05
(c) What is x-ray diffraction? Give detail idea about Bragg’s law. 05
Q.4 (a) Explain instrumentation and applications of GC-MS/MS. 06
(b) Describe the principle and procedure involved in the solid phase extraction 05
(c) Explain calibration of Fluorimeter 05
Q.5 (a) Write the principle involved in NMR spectrometer. Add a note on factors 06
affecting on Shielding and de -shielding in NMR Spectra.
(b) Write principle, instrumentation and application of proton magnetic resonance. 05
(c) Write a note on 13 C NMR 05
Q. 6 (a) Discuss in detail the validation parameter for bio-analytical methods as per ICH 06
guideline
(b) Explain validation and calibration of UV-Visible spectrophotometer. 05
(c) Discuss elements of process validation 05
Q.7 (a) What is extraction? Give detail note on liquid -liquid extraction technique. 06
(b) Define RIA? Elaborate various components of RIA 05
(c) Discuss different methods of RIA. Write application of RIA 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. SEMESTER– VIII EXAMINATION –WINTER -2022
Subject Code: BP812TT Date: 28/12/2022
Subject Name: Dietary Supplements & Nutraceuticals
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Define & classify Nutraceuticals in detail with examples. 06
(b) Write about nutraceuticals and dietary supplements used for management of 05
cancer.
(c) Write a note on prebiotics & probiotics. 05
Q.2 (a) Describe the role of free radical in initiation and progression of inflammation 06
and kidney damage.
(b) Explain the role of complex carbohydrates as functional foods along with 05
examples.
(c) Write a note on sulphur compounds as nutraceuticals. 05
Q.3 (a) D i scuss occurrence, chemical nature medicinal benefits of Carotenoids. 06
(b) Write the sources, marker compounds, medicinal uses and health benefits of 05
flax seeds.
(c) Explain the effects of processing & storage conditions on nutraceuticals. 05
Q.4 (a) Enlist various endogenous and exogenous antioxidants. Write the biological 06
role of superoxide dismutase.
(b) What are the Sources and functions of proteins as functional foods? 05
(c) Write the sources, marker compounds, medicinal uses and health benefits of 05
Spirulina.
Q.5 (a) Explain the process of free radicals mediated damage to lipids. 06
(b) Write in detail about the Nutraceuticals and dietary supplements used in 05
maternal and child nutrition.
(c) Describe role of Ascorbic acid & Tocopherols as an anti-oxidants. 05
Q. 6 (a) Discuss chemical nature & medicinal benefits of Phytoestrogens. 06
(b) What are dietary fibres? Explain their importance as functional foods. 05
(c) Write the mode of action and biological uses of catalase and glutathione. 05
Q.7 (a) Describe beverages as functional foods. 06
(b) Write a note on regulatory aspects of FSSAI on food safety. 05
(c) Write a note on free radicals theory of ageing. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM – SEMESTER–VIII EXAMINATION – WINTER -2022
Subject Code:BP814TT Date: 23/12/2022
Subject Name: Pharmaceutical Product Development
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Describe Pharmaceutical Product development process with flow chart. 06
(b) Classify types of solublizers. Discuss in detail about the different 05
pharmaceutical solublizers available in market.
(c) Write a note on stability assessment of semisolid dosage form. 05
Q.2 (a) Discuss quality control test of capsule dosage form. 06
(b) Explain in brief about excipients used for cream. 05
(c) Write a note on Emulsifying agent. 05
Q.3 (a) Enumerate different types of disintegrant. Discuss in brief about 06
Superdisintegrant.
(b) What is QbD? Describe advantages and challenges of QbD approach. 05
(c) Enumerate different types of packaging materials. Discuss glass as a packaging 05
material.
Q.4 (a) Enumerate ideal requirements of excipients used for Aerosol. Discuss about 06
Propellant.
(b) Describe properties, types and applications of Cyclodextrins. 05
(c) Discuss use and applications of factorial design in product development. 05
Q.5 (a) Classify types of excients used in tablet. Explain Diluents and Binder. 06
(b) Discuss selection criteria and quality control test of plastic as a packaging 05
material.
(c) Write a note on Polyethylene glycols and Sorbitol’s. 05
Q. 6 (a) Classify type of closures. Discuss quality control test of closures. 06
(b) Write a note on Enteric and Non Enteric coating excipients. 05
(c) Describe criteria for selection of excipients for parenteral dosage form. 05
Q.7 (a) Describe objectives of optimization techniques in Product development. 06
Explain various parameters of optimization techniques.
(b) Enlist directly compressible excipients. Explain any two in detail. 05
(c) Write a note on excipients used for formulation of NDDS. 05
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