CS/M.

Pharm/Oddl/SEM-1/MPT-1064/2018-19

MAULANAABUL KALAMAZAD
UNIVERSy OF ITECHNOLOGT,
wEST SENGAL

Utech

m OF
MAULANA ABUL KALAM AZAD UNIVERSITY
TECHNOLOGY, WEST BENGAL
Paper Code :MPT-1064
REGULATORY AFFAIRS
Full Marks: 70
Allotted: 3 Hours
The figures in the margin indicate full marks

in their own words

to give their answers
Candidates are required
as faras practicable.

Group- A
Questions)
(Multiple Choice Type
1x10=10
ten of the following:
alternative for any
Choose the correct

)a) Hatch-Waxman
Generic Drugs
Act deals with
(b) Branded Drugs
None of these
(d)
and (b)
(c) Both (a)
are included in
clinical trial requirements
ii) In Indian regulations Schedule Y
b)
ScheduleM P
(a) (d) Schedule
N
(c) Schedule are included
in
Practices
Good Manufacturing Y
(iii)
In Indian regulations (b) Schedule

La) Schedule M (d) Schedule

P

(c) Schedule
N number
is included in ICH guideline
Risk Management (b) Q9
(iv) Quality
(a) Q8 (d) Q7
(c) Q10

(v) DMF stands for (b) Data

Master File

Master File None of these

a)Drug File
(d)
Master
(c) Delivery

Turn Over
CS/M.Pharm/Oda//SEM-1/MPT-1064/2018-19

(vi) Acceptable disintegration time of an uncoated compressed tablet is usually

(a) less than 120 mins.

(b) less than 90 mins.
(c) less than 60mins. (d) less than 30 mins.
(Vin) Cross contamination and mix up at production site can be prevented by
(a) unidirectional flow of materials.

(6) using same production are for different formulations.

(c) multidirectional flow of material.

(d) stopping
production.

(vii) In IndiaNew Drug Application is made as per

(a) NDA
b) ANDA
(c) Schedule Y
(d) Schedule M
ix) HVAC system stands for
(a) High Volume Air Conditioner
b) Heat Ventilation & Air Condition
(c) Humidity Ventilation & Air Condition (d) Volume &Air Condition
Humidity
x) Number of
Healthy Volunteer for Phase
required I CIinical Trial is
(a) 200-800
(b) 2000-8000
20-80 (d) None of these
(xi) When the population is large, sampling is done from
(a) first ten units.
(b) last ten units.
(c) each of the units.
(d) the units in random in statistical way.

Group- B
(Short Answer Type Questions)

Answer any three of the

following. 5x3=15
2. Describe Phase III Clinical Trial as per Schedule Y.
requirements

3. Describe BA/BE studies as per Schedule Y.

4. Define MFR and write some of the

points included in MFR.

5. What is Site Master File?

6. What are ICH Guidelines and its need in 1CH-Q, ICH-S, ICH-E, ICH-M
(Write any two)?
 CS/M.Pharm/Oddl/SEM-1/MPT-1064/2018-19

Group -C
(Long Answer Type Questions)
15x3-45
Answerany three of the following.

number and
7. Describe ANDA CID FORMAT for Quality Module of a drug product mentioning section

titles.

about Drug Term Act.

8. Explain biefly
Price Competition and Patent Restoration

brochure. 10+5=15
9. Write the significances, principles
and contents of IND.Write about investigators

10. Describe about various regulatory guidelines followed by Pharma industries.

 CS/M.Pharm/Odd/SEM-1/MPT-1061/2018-19

MAULANA ABUL KALAM AZAD

LOGY,
ONivEe WEST BENGAL

Utech

MAULANA ABUL KALAM AZAD UNIVERSITY OF

TECHNOLOGY, WEST BENGAL
Paper Code
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
: MPT-1061

Full Marks: 70
Time Allotted: 3 Hours
The figures in the margin indicate full marks.

Candidates are required to give their answers in their own words

as far aspracticable.

Group- A
(Multiple Choice Type Questions)
1x10=10
alternative for any ten of the following questions:
1. Choose the correct

) Which

(a)
of the

Aspirin
following compounds
does not absorb light in the

(b) Paracetamol
UV/visible spectrum?

Chloral
(d) Phenobarbitone
(c) hydrate

of m/z 13 in a mass
with a molecular 1on
Which of the following formulae is consistent
(11)

spectrometry experiment?

(a) CaHN2
(b) CHN
(d) CaHNO
C)CHi00
used for XRD applications?
of X-ray are commonly
ii) Which wavelengths nm
(b) 10 nm to 100
0-05 nm to 0-25 nm
(a)
All of these
(d)
5 nm to 25 nm
(C)

is within
UVradiation
(iv)
(b) 780nm-2000 nm
(a) 180-780 nm
(d) None of these

(c) 50-180 nm

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S/M.Pharm/Odd/SEM-1/MPT-1061/2018-19

() Monochromator of IR spectrophotometeris made of

(a) Quartz (b) Glass

(c) Alkali
sulphate (d) Alkali halides

(vi) Which of the following is most nonpolar solvent?

Hexane
(a)
(b) Acetone

(c) Butanol
(d) Ethyl acetate

(vii) Isopropyl chloride has

(a) 1-PMR signal (b) 2-PMR signals

(c) 3-PHR signals (d) No signal

(vii) Molecular ion is better visualized in

(a) chemical ionization

(b) electronic ionization

(c) Both of these (d) None of these

ix) The tallest peak in the mass spectrogram is called as

(a) base peak (b) molecular ion peak

(c) isotopic abundance peak (d) metastable ion peak

(x)Which ofthe following Correlation Spectroscopy provides carbon-13 and proton shifts of nuclei in

CH bonds as cross signals?

(a) COSY (b) HMQC

(c)HMBC (d) NOESY

Cxi) Which of the following is the order of chemical shift (in units of 8) for the molecules
CHC
CH Cl2 and CH,C1?

(a) CHC> CH,Clh > CHC (b) CH,Cl, > CHCl> CH,CI

(c) CH,CI> CH,Clh > CHCl (d) CH,Clh> CHCl> CH,CI

 CS/M.Pharm/Odd/SEM-1/MPT-1061/2018-19

Group- B
(Short Answer Type
Questions)
Answerany three of the
following. 5x3=15
2. Briefly describe Capillary
electrophoresis.

3. What do mean by "C NMR

you
spectroscopy? How is it different from H NMR? What its
application.

142+2-5
4. Write down the of RIA.
principles What are the of RIA?
applications 3+2-5
5. Discuss the of X-ray
principle
Crystallography. What do you mean
by Constructive and Destructive
interference?
3+2-5
6. Define fingerprint region, Fermi resonance and overtone
with examples. 1+2+2-5

Group-C
(Long Answer Type Questions)
Answer any three of the
following. 15x3-45

7. What is factor in
plate chromatography? What is
ion-exchange and soap chromatography'? Separation
GC by
depends on volatility of the compounds
explain. the role of chemistry of compounds in
Explain
being separated by Reverse phase HPLC-with examples and compound structures. 3+4+3+5=15

8. Fermi resonance and overtones can create IR-

ghost peaks in discuss with examples. The basic of IR
spectra is
polarity of the molecule- Explain the relative of sp3, sp2 and sp
explain. peak position
hybridized groups in IR spectra and justify it with their chemistry (which one more up-field and which
one is most downfield and why). Enumerate different IR
types of bending vibrations in
spectra.

4+3+4+4=15

9. What is
hyperchromism and hypochromism? Explain with example. What is solvent shift? More polar is

the solvent, more is the solvent shift- why? From electronic transition, please how many peaks
predict
would "'acetamide" (CH3-CONH,)show in UV spectra? Explain DNA gel electrophoresis.

4+3+3+2+3=15

10. (a) Draw a neat schematic diagram of an X-ray tube and label its parts.

(b) Write about some of the important applications of X-ay crystallography.

c)ExplainBrgg's law
d) What are the differences between power diffractometer and a rotating crystal difractometer?
CS/AM.Pharm/Odd/SEM- 1/MPT-1061/2018-19

11. Define spin-spin coupling and constant.

valuable
coupling Spin-spin coupling and coupling
information about the constant Dre
structure of a compound- explain with examples. The
NMR was produced by one of followine 1
spectrum the molecules listed at the right. IH
3+-7+5-15

B
C:
PPM N-CHy
 CS/M.Pharm. /Odd/SEM-1/MPT-1063/2018-19

MAULANA ABUL KALAM AZAD

UNIVERSITY OF TECHNOLOGY,
WEST BENGAL

Utech

MAULANA ABUL KALAM AZAD UNIVERSITY OF

TECHNOLOGY,WEST BENGAL
Paper Code
MODERN PHARMACEUTICS
: MPT-1063

Time Allotted: 3 Hours Full Marks: 70

The figures in the margin indicatefull marks.

Candidates are required to give their answers in their own words

asfaras practicable.

Group A -
(Multiple Choice Type Questions)

1. Choose the correct alternative for any ten of the following:

1x10=10

) The equation used in

(a) Laplace Equation

stability testing theory is

(b) Arrhenius Equation

(c) Einstein Equation (d) None of these

(i) In a 3 factorial design

(a) 3 levels; 2 = factors (b) 3 =factors; 2 =levels

(c) Both (a) and (b) (d) None of these

ii) In order to screen the most important factors in an experiment, the best design among the following

(a) Mixture design (b) RSM

(d) Fractional factoial design
(c)Factorialdesign

(iv) In immediate release % dissolution in 0.1IN HCL in 15 minutes can ensure that the

bioavailability of the drug is not limited by dissolution.

(a) 100 (b) 50

(c) 85 (d) 25

9119 Turn Over

 CS/M.Pharm. /Odá/SEM-1/MPT-1063/2018-19

(v) Full form of HVAC is

Humid Ventilation Air

Air Conditioning (b) Conditioning
(a) Heating, Ventilation
Heat Vacuum Air Circulation
(c) Humid Variable Air Cooling (d)

in
the dispersionis
of expansion of large
at expense of smaller particles
(vi) The phenomenon particles

known as
(b) Ostwald Ripening
(a) Coalescence
(d) Phase inversion
(c) Cracking
is
with antimicrobial property
(vii) An emulsifier strong
(b) CTAB
(a) SLS Poloxamer 189
(d)
(c) Span 20
data is called as
based on historical
(viii) Process validation
(b) Retrospective

(a) Prospective (d) Revalidation

(c) Concurrent
volume is done by
Determination of
true
(ix) (b) Fisher Sub Sieve

(a) Mercury Displacement (d) Helium Pycnometer

(c) Quantasorb
is
particle
(x) as:ay for spherical (b) 1:6

(a) 6:1 (d) 4:1

which is
a zeta potential
()1:5 surfactant may have
a non ionic
stabilized by positive
(xi)
A dispersion
(b) Highly

Can't be commented
(a) Highly negative (d)

zero
(c) Near

Group -B
Sx3=15
Answer Type Questions)
(Short
three of the following.
Answer any stability
physical
and its role in providing and practical
an antacid limitation
behaviour of its assumption,
the rheological Highlight
2. Explain equation?
Analysis
Regression
3 What is Multiple
and Retrospective
Validation?

consideration.
between Prospective products?
the difference of pll of parenteral
4. What is for selection
to be considered bonding?
and fusion
the factors
5. What are cold wiclding
of lubrication,
6. What is cocfficient
 CS/M.Pharm. /Odd/SEM-1/MPT-1063/2018-19

Group -C
(LongAnswerType Questions)

Answerany three of the following. 15x3-45

7. Following ICH how

guideline, to measure Accuracy, Precision, Robustness, Linearity, Range of an
analytical method? Write the differences between calibration and validation of instrument. 10+5=15

8. Effect of force and die wall

ejection on compression of tablets. Explain the energy involved in
compaction. 7hx2=15
9. Define and explain HLB. Write a note on zeta potential. Define and explain Critical Micellar
Concentration.Enlist the evaluation for emulsion.
tests 3+5+5+2=15
10. (a) lustrate the techniques of
drug-excipient compatibility study in brief, comparing and contrasting
among themselves.
(6) Discuss the concept (not
methodology) of stability testing in the light of chemical kinetics.

72+7=15
11. (a) Distinguish between large and small volume
parenteral.

(6) Describe the common evaluation tests to be carried out on parenteral products.

(c) Predict the fact of two suspensions

product whose inter-particulate positions are given in the
following diagrams. Justify your answer. 1+10+2+2=15

a)
b)

12. Explain Student's t-distribution. In a preclinical test the

carcinogenicity potential of a new compound is
determined by administering doses A
several
of different groups of controlanimals.
group (placebo) is
included in the study as reference. One of the dose groups showed an incidence of the carcinoma is 32
of
60 animals. The control group exhibited 12 carcinoma in 65 animals. Is there any difference in the

proportion of animals with the carcinoma in the two groups?

(Tabulated critical value ofX6951 =384 3+12-15

 CS/M.Pharm/Odd/SEM-1/MPT-1062/2018-19

MAULANA ABUL KALAM AZAD

WEST BENGAL

Utech

MAULANA ABUL KALAM AZAD UNIVERSITY OF

TECHNOLOGY, WEST BENGAL
Paper Code
DRUG DELIVERY SYsTEM
: MPT-1062

Full Marks: 70
Time Allotted: 3 Hours
the margin indicatefiull marks.
Thefigures in
their own words
give their answers
are required in
Candidates to

asfaraspracticable.
The questions are of equal value.

Group-A
(Multiple Choice Type Questions)
1x10-10
for any ten of the following questions:
1. Choose the correct alternative
in case
or partially within a drug reservoir compartment
0) A drug formulation is totally encapsulated

of
drug delivery system.
(a) Polymer membrane permeation-controlled

systems.
(b) Polymer matrix diffusion-controlled drug delivery

Microreservoirpartition-controlled drug delivery system.

(c)

(d) None of these

done the
an aqueous suspension of drug is using following biocompatible
ii) Microdispersion of
polymer
(b) Silicone elastomer
(a) PEG-6000
(d) None of these
(c) Poly-vinyl ethylene
device
A material with the ability to draw water into the porous network of an osmotie delivery
(ii)

(b) Pore forming agent

(a) Wicking agent
(d) None of these
(c) Osmogen
(iv) Given below are the examples of synthetic biodegradable polymers except

(a)
(b) Dextran
Polyorthoesters

(c) Polyanhydrides (d) Polyphosphazenes

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CS/M.Pharm/Odd/SEM-1/MPT-1062/2018-19

(V) Which of the

following system utilizes ultrasonic
energy to activate or the delivery
trigger af
rom polymeric delivery device?
drug drug
(a) Phonophoretic (b) Magnetic
(C) Mechanical d) Bioactive
(vi) A desktop 3D printer for biomaterials, combines hardware, software and
wetware is
(a) Westem Blot
(b) Eastern Blot
(c) Southern Blot
(d) Bio Blot
(vii) The delivery of care via
pharmaceutical telecommunication is knownas
(a) Telepathy
(b) Telemedicine
(c)
Telepharmacy
d) Telecare
(vii) Which of the is
following the rate
determining step of CRDDS?
(a)
Disintegration
(c)
(b) Partition coefficient
Diffusivity
(d) Molecular
ix) The potential side weight
effects of vaccine
drug delivery is/are
(a) Fever

(c) Muscle aches (6) Pain around the

injection site

(x) Shear (d) All of these

strength test is
perfomed to evaluate
(a) Adhesive
Tack (b)
(c)
property
Drug release

(d)
(xi) In vitro skin Sensitivity
permeation studies are
(a) Live human skin performed by using which of the
following?
b) Human cadaver skin
)Live rabbit skin
(d) Backing membrane

Group-B
(Short Answer
Type Questions)
Answer any three of the
following.
2.
Distinguish between on demand 5x3=15
system and self
regulated system in
3. How do protein
oral vaccines delivery.
induce
immunity? Enumerate the role of
liposome as vaccine
4. Derive the delivery system.
equation of release
kinetics of drug from 3+2-5
core-shell
5. Discuss the delivery devices.
importanceof aqueous
solubility, log P and
6. Write a pKa of a drug for
note on oral
controlled
bioelectronic release
medicine. delivery
 CS/M.Pharm/Odd/SEM-1/MPT-1062/2018-19

Group-C
(Long Answer Type Questions)
Answer any three of thefollowing 15x3-45

7. Explain the difficulties of Vaccine delivery system. Explain the delivery of vaccine through mucosal and

transdermal delivery. 5+5+5-15

8. What is the principle of 3D printing technology? Discuss on 3D printed drug delivery devices. Why drugs
with t/2 2 is unsuitable for oral controlled released delivery?
3+7+5-15

9. (a) Write in details about the various barriers of drug permeation in ocular drug delivery systems.

(b) Write down the principle and theories of mucoadhesion. 7.5+7.5-15

10. (a) Enlist the advantages and disadvantages of SR dosage form.

6) Discuss about Physico-chemical and Physiological

factors to be considered in SR/CR dosage form.
2+13=15

11. Write notes on the following: 5x3=15

(a) Occuserts

(b) Natural polymer

(c) Permeation enhancer in Transdermal drug delivery system