Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Ph. – SEMESTER– VIII EXAMINATION – SUMMER -2022
Subject Code: BP801TT Date: 31/05/2022
Subject Name: Biostatistics and Research Methodology
Time: 10:30am to 01:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Ph. – SEMESTER– 8 EXAMINATION – SUMMER -2022
Subject Code: BP802TT Date: 02/06/2022
Subject Name: Social and Preventive Pharmacy
Time: 10:30am to 01:30pm 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 public health. How to evaluate? Explain in detail 06
(b) Describe social causes of diseases. 05
(c) What do you understand by Balanced diet? Discuss nutritional requirement in Food. 05
Q-2 (a) Give prevention and control for dengue 06
(b) Write a note on control of SARS 05
(c) How we can stop drug addiction-drug substance abuse? 05
Q-3 (a) What do you understand by DOTS program? Discuss in detail about it 06
(b) Write a short note on HIV and AIDS control program. 05
(c) Give relevance of Universal immunization program in Current Covid-19 pandemic. 05
Q-4 (a) Discuss National family welfare program. 06
(b) How we can minimize tobacco use? Discuss tobacco control program. 05
(c) Explain role of WHO in Indian national program 05
Q-5 (a) Give role and functions of PHC in public health 06
(b) Discuss National urban health mission 05
(c) How we can promote Health awareness at school? 05
Q-6 (a) Discuss avoidable habits with reference to personal hygiene 06
(b) How to control occurrence of malaria? What are the medications for treatment? 05
(c) Write a short note on Pulse polio program 05
Q-7 (a) White a note on Vitamin B12 deficiencies 06
(b) Give a note on preventive measure for hemoglobin deficiency in women and its remedies. 05
(c) Explain Impact of urbanization on health and disease 05
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm- SEMESTER– VIII • EXAMINATION – SUMMER -2022
Subject Code: BP803TT Date: 06/06/2022
Subject Name: Pharma marketing Management
Time: 10:30am to 01:30pm 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 marketing. Explain various scope and functions of marketing. 06
(b) Write difference between marketing and selling. Write stages of buying 05
process.
(c) Write a note on motivation and prescribing habits of the physician. 05
Q.2 (a) Zen Pharmaceuticals company is planning to launch cosmetic products, discuss 06
marketing research for that product market success.
(b) Describe factors affecting consumer buying behavior. 05
(c) Describe product life cycle stages. 05
Q.3 (a) Describe various stages for development of new pharmaceutical product. 06
(b) What is product branding? Write types of brand names with examples. 05
(c) Discuss various types of product policy decision to improve market size. 05
Q.4 (a) Discuss various sales promotional activities for excisting product and new 06
product.
(b) Define promotional budget. Discuss methods of determination of promotion 05
budget.
(c) Describe different marketing strategies /techniques for OTC products. 05
Q.5 (a) Explain marketing channel. Discuss role and functions of middlemen. 06
(b) Write a note on personal selling. 05
(c) When channel conflict arises, explain types of conflicts with causes of it arise. 05
Q. 6 (a) Explain the following: Vertical marketing, Rural marketing, Industrial 06
marketing
(b) Write a detail note on emerging concepts in marketing 05
(c) Mr. Shushil is head of marketing in X pharma company to overcome the 05
destructive channel conflicts, which policies/solutions he will implement.
Q.7 (a) What are duties of professional sales representative (PSR). Discuss importance 06
of training to PSR.
(b) Explain major determinants of price of product. 05
(c) Describe pricing methods and strategies. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER- VIII-EXAMINATION – SUMMER -2022
Subject Code:BP804TT Date:06/06/2022
Subject Name: Pharmaceutical Regulatory science
Time: 10:30am to 01:30pm 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 new drug according to FDA. Explain in detail the new drug 06
development process with the time course for each phase.
(b) Explain the approval process of new drug under 505 (b) (2). 05
(c) Discuss about various Stages of drug discovery. 05
Q.2 (a) Write a note on Preclinical studies as per CDSCO. 06
(b) Discuss about Organization structure and Overview of regulatory authorities of 05
India.
(c) Describe general consideration, specific requirements and contents of an NDA. 05
Q.3 (a) Describe the procedure for Generic drug approval from CDSCO in India. 06
(b) Explain the purpose and procedure for IND application to USFDA. 05
(c) Describe Informed Consent process and procedures for clinical trial study. 05
Q.4 (a) What is the importance of investigator’s brochure? Give a brief outline of 06
clinical research protocols.
(b) What is Common Technical Document? Describe various CTD modules. 05
(c) Write a note on International Good Clinical Practices. 05
Q.5 (a) Describe how Waxman-Hatch Act has simplified and facilitated approval of 06
generic products in US?
(b) What is DMF? Write a note on Type of DMF. 05
(c) Discuss content of ASEAN Common Technical Document. 05
Q. 6 (a) How did Bolar provision give boost to ANDA approval process in USA? 06
(b) Give the composition, functions and responsibilities of Institutional review 05
board.
(c) Briefly explain about Safety monitoring of medical products. 05
Q.7 (a) Write scope and approaches of 21 CFR part 11. 06
(b) Write note on Purple book. 05
(c) Discuss the salient features of FDA guidelines for clinical trials in India. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. – SEMESTER–VIII • EXAMINATION – SUMMER -2022
Subject Code: BP805TT Date: 04/06/2022
Subject Name: PHARMACOVIGILANCE
Time: 10:30am to 01:30pm 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 active surveillance in pharmacovigilance. 06
(b) Write about pharmacovigilance program in India. 05
(c) Write about International classification of diseases. 05
Q.2 (a) Write about history and development of pharmacovigilance. 06
(b) Discuss on differences in Indian and global pharmacovigilance requirements. 05
(c) Write on basic drug information resources in pharmacovigilance. 05
Q.3 (a) Define and classify ADRs in details. 06
(b) Write about CROs in pharmacovigilance. 05
(c) Explain about eudravigilance medicinal product dictionary. 05
Q.4 (a) Discuss in details about case control and cohort study. 06
(b) Write about effective communication in pharmacovigilance. 05
(c) Explain about genetic related ADR. 05
Q.5 (a) Write about D&C act and schedule Y in pharmacovigilance. 06
(b) Explain about good clinical practice in pharmacovigilance study. 05
(c) Discuss basic terminologies used in pharmacovigilance. 05
Q. 6 (a) Discuss drug safety evaluation in pregnancy and lactation. 06
(b) Write about periodic safety update reports. 05
(c) Write a note on vaccination failure. 05
Q.7 (a) Write down organization and objectives of ICH. 06
(b) Discuss on pharmacovigilance of vaccine. 05
(c) Write about post approval phase. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. – SEMESTER 8 -EXAMINATION – SUMMER -2022
Subject Code:BP806TT Date: 04/06/2022
Subject Name: Quality Control and Standardization of Herbals
Time: 10:30am to 01:30pm 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) Enlists the parameters of WHO guidelines for quality control of herbal drugs. 06
Write a note on Ash Value and Extractable matters of herbal drugs.
(b) Discuss the Volatile oil determination for herbal drugs. 05
(c) Explain the Chemical tests for anthraquinone and cardiac glycosides. 05
Q.2 (a) Explain the importance of Good Manufacturing Practices for herbal medicines 06
(b) Discuss the determination of Pesticide residue from herbal drugs. 05
(c) Write a note on the evaluation of polyherbal tablet formulation. 05
Q.3 (a) Write a note on WHO guideline for Good Agriculture and Collection Practices 06
of medicinal plants.
(b) What is importance of Quality assurance in herbal drug Industry? Discuss in 05
details.
(c) Write a note on Good Laboratory Practices in herbal medicines. 05
Q.4 (a) Write a note on EU guideline for quality control of herbal drugs. 06
(b) Discuss Good agriculture practice in cultivation of medicinal plants. 05
(c) Explain the safety guideline for herbal medicines. 05
Q.5 (a) Write a brief note on Guidelines for Toxicity investigation of Herbal medicines 06
(b) Discuss the guideline for efficacy evaluation of herbal medicines. 05
(c) Explain the guideline for clinical trials using herbal medicines 05
Q. 6 (a) Explain the stability testing of herbal medicines. 06
(b) Write a note on application of HPLC and Gas Chromatography technique in 05
standardization of herbal products.
(c) Discuss the preparation of New Drug Application for herbal medicines 05
Q.7 (a) What is phytopharmacovigilance? Discuss the safety monitoring aspects of 06
herbal medicines through phytopharmacovigilance.
(b) Write a note on Herbal Pharmacopoeias. 05
(c) Discuss the role of biological markers in standardization of herbal products. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. -SEMESTER–VIII • EXAMINATION – SUMMER -2022
Subject Code: BP807TT Date:06/06/2022
Subject Name: Computer Aided Drug Design
Time:10:30AM TO 01:30PM 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) What is molecular mechanics? Discuss its applications in details. 06
(b) Write a note on lead discovery based on drug metabolism. 05
(c) Discuss about Hansch analysis in QSAR. 05
Q.2 (a) Write down various stages of drug discovery and development. 06
(b) Write a note on quantum mechanics in drug discovery. 05
(c) Define drug likeness. Discuss about virtual screening of drug likeness. 05
Q.3 (a) Define Bioisosterism. Discuss classification & bioisosteric replacement in 06
details.
(b) Write a note on de novo drug design. 05
(c) Discuss in details about concept of pharmacophore mapping. 05
Q.4 (a) Write about COMFA and COMSIA methods of 3D-QSAR. 06
(b) Write about serendipitous drug discovery in details. 05
(c) Discuss in details about ADME databases. 05
Q.5 (a) Write about energy minimization methods in molecular modeling. 06
(b) Differentiate between SAR and QSAR in details. 05
(c) Write a note on pharmacophore based screening. 05
Q. 6 (a) Define docking. Discuss various docking methods. 06
(b) Write about free wilson analysis in QSAR. 05
(c) Discuss in details about bioinformatics in drug design. 05
Q.7 (a) Discuss various physicochemical parameters in QSAR. 06
(b) Write about global conformational minima determination. 05
(c) Write a note on lead discovery based on clinical observation. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. SEMESTER- VIII-EXAMINATION – SUMMER -2022
Subject Code: BP808TT Date: 06/06/2022
Subject Name: Cell and Molecular Biology
Time: 10:30am to 01:30pm 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) Briefly explain about Transfer RNA (tRNA). 06
(b) Explain the history of cell biology. 05
(c) Explain the structure of microtubules. 05
Q.2 (a) Briefly explain about the prokaryotic and eukaryotic cell with neat diagram. 06
(b) What is meiosis? Describe the various stages of meiosis division. 05
(c) Describe the structure and function of bacterial cell wall. 05
Q.3 (a) What are the check points and their role in Cell cycle? 06
(b) Write an account on nucleosomes. 05
(c) Explain the regularities in protein pathways. 05
Q.4 (a) Give a short note on Transcription. 06
(b) Write a note on the central dogma. 05
(c) Outline the positive control and significance of protein synthesis. 05
Q.5 (a) Explain about mitosis. 06
(b) Define cell and molecular biology. 05
(c) Outline of the properties of cells and cell membrane. 05
Q. 6 (a) Define the term “secondary messenger”. Briefly describe the role of these 06
molecules in signalling pathway.
(b) Differentiate between DNA and RNA. 05
(c) Explain in detail about the DNA functions. 05
Q.7 (a) List and briefly define the stages of cell signaling. 06
(b) Write a note on protein kinase. 05
(c) Discuss about the misregulation of cell signalling pathways. 05
***************
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Ph. SEMESTER- VIII-EXAMINATION – SUMMER -2022
Subject Code: BP809TT Date: 04/06/2022
Subject Name: Cosmetic Science
Time: 10:30am to 01:30pm Total Marks: 80
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Ph. SEMESTER – VIII-EXAMINATION – SUMMER-2022
Subject Code: BP810TT Date: 04/06/2022
Subject Name: Experimental Pharmacology
Time: 10:30am to 01:30pm 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) List out the different laboratory animals (indicate species and strains) used for Preclinical 06
experiments. Discuss in brief the applications of Rat.
(b) Write in brief about use of transgenic animals in Preclinical Research. 05
(c) What is euthanasia? Discuss CPCSEA approved methods of euthanasia. 05
Q.2. (a) Explain the following in brief (any two): 06
1.Sham and Positive Control 2. Human Equivalent Dose 3. Research Hypothesis
(b) Write a note on the student’s ‘t’ test. 05
(c) Discuss the animal/preparation preferred for preclinical evaluation of the following: 05
1. Antihistamines 2. Intradermal local anesthetics 3. Mydriatics
4. NSAIDs 5. Breast cancer
Q.3. (a) Enumerate models used for screening of Parasympatholytics. Discuss any one in vivo 06
model.
(b) Discuss in brief in vitro methods for screening of sympathomimetics 05
(c) Discuss the pharmacological evaluation of Neuromuscular blockers. 05
Q.4. (a) Enumerate methods for evaluation of Antialzheimer agents. Discuss the parameters used 06
for assessment of Alzheimer’s disease in preclinical models.
(b) Outline the models used for screening of antidepressants. Write in brief about the Porsolt 05
test.
(c) Discuss in brief the evaluation of sedatives. 05
Q.5. (a) Classify the methods used for evaluation of analgesics. Describe the thermal 06
method in brief.
(b) List out methods for screening of antiepileptics. Discuss in detail MES model. 05
(c) Enlist the models used for Antiparkinson activity. Discuss in detail the MPCP model. 05
Q.6. (a) Enumerate animal models of type I Diabetes. Discuss the use of Streptozotocin in 06
preclinical research.
(b) Enumerate models used for hypertension. Describe surgically induced 05
hypertension models in brief.
(c) Enumerate models used for screening of Antiasthmatics. Discuss any one method 05
for evaluation of Bronchodilators.
Q.7. (a) Explain the use of following in Preclinical screening: (any two) 06
1. Cooke’s pole 2. Morris Water Maze 3. Plethysomometer
(b) Discuss in detail the Lipschitz model for evaluation of diuretics. 05
(c) Enumerate the models used for inducing dyslipidemia. Discuss in brief Triton 05
induced model.
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm. – SEMESTER–VIII • EXAMINATION – SUMMER – 2022
Subject Code: BP811TT Date: 06/06/2022
Subject Name: Advanced Instrumentation Techniques
Time: 10:30am to 01:30pm 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) Draw schematic diagram of modern thermobalance. Discuss factor affecting 06
thermogravimetric curve.
(b) What are the requirements of radioimmunoassay? Discuss the principle of RIA. 05
(c) Describe the difference between gaseous field ionization sources and field 05
desorption sources. What are the advantages of each?
Q.2 (a) Draw a typical DSC thermogram. Explain various stages of DSC thermogram. 06
(b) Discuss various validation parameters as per ICH guideline. 05
(c) Enumerate types of ions produced in MS. Write in detail about molecular ion and 05
isotope ion.
Q.3 (a) Define splitting. Which are the causes of splitting? Explain rules for splitting of 06
proton signals in PMR.
(b) What is the theoretical basis of DTA? Explain the difference between DTA and 05
DSC.
(c) Draw block diagram of mass spectrometer. What is the role of vacuum system in 05
MS? Discuss triple-quadrupole as a mass analyzer in MS.
Q.4 (a) Give a schematic diagram of NMR spectrometer and explain the principle of 06
NMR.
(b) Elaborate the general rules for interpretation of mass spectra. 05
(c) Define hyphenated techniques. Write in detail about LC-MS/MS or HPTLC-MS. 05
Q.5 (a) Discuss the general principle and procedure involved in liquid-liquid extraction. 06
(b) What is HDI? Write formula for calculating HDI. How are HDI and nitrogen rule 05
helpful in interpretation of mass spectrum?
(c) Draw a block diagram of GC-MS. Write in detail about interfaces used in GC- 05
MS.
Q. 6 (a) Elaborately explain applications of mass and NMR spectrometry in 06
characterization of compound.
(b) What are the differences between power compensation and heat-flux DSC? 05
Enlist the limitations of TGA.
(c) How validation is different from calibration? Discuss calibration of UV-Visible 05
spectrophotometer.
Q.7 (a) Which are the various modes of fragmentation in MS? Explain McLafferty 06
rearrangement and scrambling.
(b) Discuss factors influencing chemical shift. Give reasons for taking TMS as a 05
reference compound.
(c) How single crystal diffraction differs from powder diffraction? Write the 05
applications of X-ray diffraction technique.
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B.PHARM.- SEMESTER– VIII-EXAMINATION – SUMMER -2022
Subject Code: BP812TT Date:06/06/2022
Subject Name: Dietary Supplements and Nutraceuticals
Time: 10:30am to 01:30pm 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 Nutraceuticals and Classify them in detail. 06
(b) Narrate in brief health benefits of Ginseng. 05
(c) Write a note on Phytoestrogens as a nutraceuticals. 05
Q.2 (a) Discuss chemistry & medicinal benefits of Flavonoids in detail. 06
(b) Discuss in brief role of various minerals in human health. 05
(c) Describe about dietary fibers as functional food ingredients. 05
Q.3 (a) Describe occurrence, chemistry & medicinal benefits of Diallyl sulphides & 06
Allyl trisulfide.
(b) Write a note on Resveratrol as a nutraceuticals. 05
(c) Give any five examples of adulteration in common food ingredients. 05
Q.4 (a) Discuss in brief damaging reactions of free radicals on lipids & proteins. 06
(b) Write a note on beverages as functional foods. 05
(c) Discuss in detail a role of nutraceuticals for management of obesity. 05
Q.5 (a) Write about role of free radicals in Diabetes mellitus & Inflammation. 06
(b) Write a note on synthetic antioxidants. 05
(c) Discuss in detail Prebiotics & Probiotics. 05
Q. 6 (a) Discuss in detail Vitamin C & Vitamin E as an antioxidants. 06
(b) Describe a role of free radicals in kidney damage & muscle damage. 05
(c) Discuss the effects of processing & storage on the potential of nutraceuticals. 05
Q.7 (a) Write a note on Pharmacopoeial specifications for dietary supplements. 06
(b) Give biological source, chemical nature, medicinal uses and health benefits of 05
Spirulina.
(c) Write a note on maternal and child nutrition in detail. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
B. Pharm – SEMESTER –VIII EXAMINATION – SUMMER -2022
Subject Code:BP814TT Date:04/06/2022
Subject Name: Pharmaceutical Product Development
Time: 10:30am to 01:30pm 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) What is Cyclodextrin? Give its applications in pharmaceutical product 06
development
(b) Define Solvents. How solubilizers play important role in dosage form design? 05
(c) Explain the ICH guidelines related to stability assessment of a dosage form. 05
Q.2 (a) Describe the mechanism of action for different suspending and emulsifying 06
agents with suitable examples.
(b) Explain in detail – quality control testing parameters of Tablets. 05
(c) Write a note on – excipients in parenteral and aerosols products. 05
Q.3 (a) Discuss selection and application of excipients for controlled drug delivery. 06
(b) How selection of coating materials play crucial role in release pattern of the 05
dosage form?
(c) Write a note Polyethylene glycols as solubility enhancer for poorly soluble 05
drugs.
Q.4 (a) What is IPQC? Explain its importance with suitable example of a dosage form. 06
(b) Explain role of factorial designs in optimization of a pharmaceutical 05
formulation.
(c) What is QbD? Give its application in pharmaceutical product development. 05
Q.5 (a) Write a note on container closure system for semi-solid dosage forms. 06
(b) Describe various quality control testing of packaging materials for 05
pharmaceutical products.
(c) What are the different selection criteria for glass- as packaging material for 05
injectable products?
Q. 6 (a) Explain plackett and burman screening design with suitable examples. 06
(b) Give application of simplex lattice design with special reference to mouth 05
dissolving dosage form.
(c) Write a note on excipients used in preparation of capsules. 05
Q.7 (a) Describe role of various excipients in semi-solid dosage form development. 06
(b) What are directly compressible vehicles? Give its applications. 05
(c) What is a mixture design? Explain with suitable example in detail. 05
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