Regulatory: Kalam OF West

Cs/M.
PHARM/ODD/SEM-1/MPT-1064/2017-18
oulana Abul KalamAzad Univorsty
Technology,WestBenga
of
Utech
MAULANA ABUL KALAM AZAD UNIVERSITY OF

TECHNOLOGY, WEST BENGAL
Paper Code MPT-1064
REGULATORY AFFAIRSs
TimeAllotted: 3Hours Full Marks :70
The figures in the margin indicatefull marks.
Candidates are required to give their answers in their owrn
words asfar as practicable.
GROUP- A
(Multiple Choice Type Questions )
1. Choose the correct alternatives for any ten of the
following:
10x 1 10
i Orange book is published in every year by
a) Govt. of India b) Govt. of Canada
US-FDA.
c)WHo d)
ii)
NDA is an abbreviated form of
a) New Drug Advertisement
b) New Delhi Drug Administration
c) New Drug Administration
d) New Drug Application.

Turn over
MPH-95383
CS/M.PHARM/ODD/SEM-1/MPT-1064/2017-18
i) Hatch-Waxman Act deals with
a) Generic drugs b) Branded drugs
c)Both (a)and (b}) d) None of these.
iv) cGMP regulation related to food additives comes
under
a) 21 CFR 170 - 199 b) 21 CFR 200 299
c) 21 CFR 300 499 d) 21 CFR 500 599.
v) A capsule filling machine is purchased. What kind
ofqualification should be performed at first?

a) Prospective b) Retrospective
c) Concurrent d None of these.
vi In which of the following conditions an IND is not
required ?
Marketed approved dosage or
a) drugs using
indication established already
b) Intended only for in vitro or animal testing
c) Certain BA/BE studies-generic drugs
d all of these.
MPH-95383 2
to educate trial
vii)
is document
facts about the trial

investigators of the significant
conduct the trial with

drug they need to know to
the least hazard to patients.
a) Investigational Brochure
b) Code of Federal Regulations
c) Cross Reference Letter
d) Categorical Exclusion.
site
vii) Cross contamination and mix up at production
can be prevented by
a) Unidirectional flow of materials
same area for different

b) Using production
formulations
Multidirectional flow of material

c)
d) Stop production.
MPH-95383 3 [ Turn over

CS/M.PHARM/ODD/SEM-1/MPT-i064/2017-18
ix) Purified water shall meet the microbiological
specification of NMT
a) 125 cfu/ml
b) 25 cfu/ml
c 100 cfu/ml
d) 150 cfu/ml.
x The current edition of cGMP contains
a) 10 volumes
b) 9 volumes
c 15 volumes
d) none of these.
xi) 21 CFR is updated on
a January 1st of every year
b) March 31st of every year
c) April 1st of every year
d) December 31st of every year.
MPH-95383
GROUP B
(ShortAnswer Type
Questions)
Answer any three of
2. Define
'RegulatoryAffairs'
the following.
? Discuss its
3x 5 15
importance in
the
Pharmaceutical sector.
2+3
3 Write short notes
on any two
of the following
2x22
a) TGA
b) USFDA
c) CDSCO
) DMF
4. Enumerate in brief the different
regulatory guidelines
followedin the
management of Pharma Industry.
5. Write on the in-vitro assessment technique of

drug
product performance.
6. Give the key

points of outsourcing of new molecules
for
BA and BE study to CRO.
MPH-95383 5 [Turn over

GROUP- C
Long Answer Type Questions)
Answer anythree of the following. 3x 15 45
7. a) What is an IND ?
b) When is an IND required?
c) What are the essential principles of an IND ?
d) What are the standard contents of an initial
IND? 2 +3+3+7
8. Explain any three of the following: 3x 5
a) Investigators Brochure (IB)
b) Institutional Review Board (IRB)
c) Clinical Research Organization (CRO)
d) Code of Federal Regulations 21 (CFR-21).
9. What is new drug development process ? What is its
importance ? Give a brief review on 'New Drug Approval
Process Regulatory requirement' in USA ? 3+3+9
MPH-95383
10. What is DMF ? Describe the various types of DMFs in
USA. Give a brief review on IND application submission
procedure to CDSCO. 2 +3 + 10
11. What is Hatch-Waxnman Act ?What is its contribution
towards generic pharma companies ? Discuss the
requirements for filing ANDA. What is CFR ?
3+4+5+3
MPH-95383 7
cS/M.PHARM/ODD/SEM-1/MPT-1064/2017-18 LIBRARY
Maulana Abul KalamAzad Universty WDHA

ol West Bengal
lechinology,
Utech
MAULANA ABUL KALAM AZAD UNTVERSITY OF

Paper Code MPT-1064
REGULATORY AFFAIRS
Time Allotted: 3 Hours Full Marks: 70
Thefigures in the margin indicate full marks.
Candidates are required to give their answers in their own
GROUP -A
(Multiple Choice Type Questions)
following: 10x 1 10
i) Orange book is published in every year by
a Govt. of India b) Govt. of Canada
c) WHO d) US-FDA.
i) NDA is an abbreviated form of
a) New Drug Advertisement
b)
b) New Delhi Drug Administration
c) New Drug Administration
d) New Drug Application.
MPH-95383 Turn over

Cs/M.PHARM/ODD/SEM-1/MPT-1064/2017-18
Act deals with
ii)
ii) Hatch-Waxman
b) Branded drugs
a Generic drugs
d) None of these.
Both (a) and (b)
c)
comes
related to food additives
iv cGMP regulation
under
21 CFR 200 299
a)
a) 21 CFR 170 199 b)
21 CFR 500 599.

c) 21 CFR 300 499 d)
is purchased.
What kind
machine
v A capsule filling
?
at first
of qualification should be performed
Prospective b) Retrospective
a)
d None of these.
c) Concurrent
an IND is not
conditions
vi) In which of the following
required?
or
Marketed drugs using approved dosage
a)
indicationestablished already
Intended only for in vitro or animal testing

b
c) Certain BA/BE studies-generic drugs
d all of these.
MPH-95383 2
Aun
cS/M.PHARM/ODD/SEM-1/MPT-1064/2017-18
educate trial
document to
******* is
facts about the trial

of the significant
investigators
with
to know to conduct the trial
drug they need
the least hazard to patients.
Brochure
a) Investigational
b) Code of Federal Regulations
Cross Reference Letter

c)
Exclusion.
d) Categorical
site
vii) Cross contamination and mix up at production
can be prevented by
Unidirectional flow of materials

a)
area for different

b) Using same production
formulations
c) Multidirectional flow of material
d) Stop production.

ix) Purified water shall meet the

microbiological
specification of NMT
a 125 cfu/ml
b)25 cfu/ml
c) 100 cfu/ml
d) 150 cfu/ml.
x The current edition of cGMP contains
a) 10 volumes
b) 9volumess
c) 15 volumes
d) none of these.
xi) 21 CFR is updated on
a) January 1st of every year
b) March 31st of every year
c) April 1st of every year
d) December 31st of every year.
MPH-95383 A
GROUP- B
(ShortAnswer Type Questions)
Answer any three of the following. 3x5 15
2. Define 'Regulatory Affairs' ? Discuss its importance in
the Pharmaceutical sector. 2+3

3. Write short notes on any two of thefollowing 2x22
a TGA
b) USFDA
c) CDSCO
d) DMF.
4. Enumerate in brief the different regulatory

guidelines
followed in the management of Pharma Industry.
5. Write on the in-vitro assessment technique of drug
product performance.
6. Give the key points of outsourcing of new molecules for
BA and BE study to CRO.

GROUP -C
Answer any three of the following. 3x 15 =45
7. a) What is an IND ?
b) When is an IND required ?
c What are the essential

principles of an IND?
d What are the standard contents of an initial
IND ? 2 +3 +3+7
8. Explain any three of the following: 5
a Investigators Brochure (IB)
b) Institutional Review Board (IRB)
c) Clinical Research Organization (CRO)
d) Code of Federal Regulations

21 (CFR-21).
9. What is new drug development process ? What is its
importance ? Give a brief review on 'New Drug Approval
Process Regulatory requirement' in USA? 3+3+9
MPH-95383 6
10. What is DMF ? Describe the various types of DMFs in
USA. Give a brief review on IND

application submission
procedure to CDscO. 2 +3+ 10

11. What is Hatch-Waxman Act ?What is its contribution
towards generic pharma companies ? Discuss the
requirements for filing ANDA. What is CFR ?
3+4+5+3
MPH-95383 7
GAL3
RY
LI9RARY
Maulana Kalam Azad
University
Abul
ol WestBenga
Technology,
Utech
UNIVERSITY OF
MAULANA ABUL KALAM AZAD
Paper Code : MPT-1062
DRUG DELIVERY SYSTEM 70
TimeAllotted 3 Hours Full Marks
marks.
the margin indicatefull
The figuresin
answers in their own
Candidates are required to give their
GROUP-A
(Multiple Choice Type guestions)
ten of the
alternatives for any
Choose the correct
1
10x 1 10
following:
for ophthalmic
of solid hydrocarbon
i) Melting point
ointment is
37C b) 34C
a)
40'C d) 25'Cc.
c)
Nanomicelles for ocular delivery should be

ii)
a) hydrophobic
b) hydrophilic
c) None of these.
Turn over
MPH-95370
I
CS/M.PHARM/ODD/SEM-1 /MPT-1062/2017-18
ii) Oral bioavailabilityof protein drug can be

increased
by
a) Protein Hybridization
b) Protein Lipidization
Use of
Vit.
B12
d) Both (b) and (c).
iv) In TDDS drug ultimately reach to
a) b) Intracellhular laye
Epithelial layer
Dermal layer
c)
d
Systemic circulation.
v)Which of the following ingredients can be used as
an encipient to prepare colon targeted controlled
release drug delivery system ?
a)
b
c)
Crospovidone
Pectin
Lactose
d) None of these.
vi) The intensity of currentflow normally used for
intophoretic transdermal drug delivery system is
a) 5 A/cm b) 25 mA/cm
c) 500 mA/cm d) none of these.
Transderm Nitro' is an example

viil)
of
a) Polymer membrane permeation controlled DDS

b) Polymer matrix diffusion controlled DDS
c) Microreservoir partition controlled DDS
DDS.
)
d) Enzyme activate
viii) 'Alzet'osmotic pump 1s a/an
a) injectable formulation
implantable formulation
c) oral formulation
d) rectal formulation.
MPH-95370
ix) For controlled release

drug delivery system, if the
rate constant of
drug release is K, and drug
absorption is then K,
a)K,» Ka b) K, << Ka
c)K, -K d) none of these.
x) Which of the following drugs are subjected to
intestinal metabolism ?
a) hydralazine bsalicylamide
c) nitroglycerine d) all of these.
xi) NLCs, Dissocubes and SLNs are examples of
a) polymeric nanoparticles
b) liposomal dispersions
c)surfactant aggregates
d) lipid nanoparticles.
xii) Drug Eluting Stents are examples of
site specificdrug delivery systems
b) localized drug delivery systemns
c)implantable drug delivery systems

d) targeted drug deliverysystems.
GROUP- B
(ShortAnswer Type Questions
Answer any three of the following. x 15 3 5=
2. Write a short note on principles of self
regulated device
used in protein delivery.
3. What are differentbarriers in drug permeation of ocular
drug delivery ? Explain briefly.
4. What is
pharmacogenetics and 3D printing of
pharmaceuticals.
2+2
MPH-95370 3 [ Turn over
5. Derive the.
equation of release kinetics of drug from
diffusion controlled matrix
type devices.
6. Discuss on importance of
aqueous solubility and pKa of
a drug oral controlled
release delivery.
GROUP- C
(Long Answer Type Questions )
Answer any three of the
7. following. 3x 15 = 45
a) Discuss the special status of
liposomes in novel
drug delivery.
b) Mention with suitable
explanations the limitations
of liposomes.
8. a) the Bio-adhesive
Classify
polymers with suitable
example of each class.
b) What are the factors affecting the mucoadhesion ?
9. Explain the different features of TDDS. Properly explain
TDDS development and evaluation methods. 5 + 10
10. Write short notes
a) pH
on any two of the following :
activated drug delivery system
77
b) Feedback regulated drug delivery system
c) Sonophoresis activated drug delivery system.
11. Explain the difficulties of Vaccine
system.delivery
Explain the delivery of vaccine through mucosal and
transdermal delivery. 5+5 +5
MPH-95370 4
cS/M.PHARM/ODD/SEM-1/MPT-1061/2017-18
Maulana Abul KalamAzad Unversity
of West Bengal
Technology.
Utech

: Paper
MODERN PHARMACEUTICAL ANALYTICAL
Code MPT-1061
TECHNIQUES
Time Allotted: 3Hours Full Marks: 70
The figures in the margin indicate full marks.
Candidates are required to their answers in their own

give
words as far as practicable.
GROUP-A
Multiple Choice Type Questions )
following
10x 1 10
is
i) Shielding constant given by
a) 1-(H/HO) b) 1-(HO/H)
d) (HO/H) - 1.
c) (H/HO)-1
ii) FTIR instrument records a signal in the
a) Time domain
b) Frequency domain
c) Both time and frequency domain
d) None of these.
MPH-95365 |
Turn over
iii) The main technique used to analyze crystal
structure of a sample is
a Gas chromatography
b) X-ray diffraction
c) Atomic absorption
spectroscopy
d) UV-Vis spectroscopy.
iv) Quartz cuvette is used is UV spectrophotometer

because glass cuvette
a) Absorbs visible light
b) Absorbs UV light
c) Reflects visible light
d) Reflects UV light.
v The fluorescent dye used in the agarose gel
electrophoresis is
a) Ethidium bromide
b) Bromophenol blue
c) Xylene cyanole
d) none of these.
MPH-95365 2
vi) Upon increase of the numbers of conjugated
dienes, there will be
a) Blue shift b) Red shift
c) Green shift d) Violet shift.
maxima of benzene changes from 255

vii) Absorption
nm to 280 nm, when the auxochrome.. 1S

added to benzene ring.
a)-NHCH b)-OH
c -OCH3 d)-NH2
vii) According to Woodward-Fisher rule, parent value of
conjugated diene
is
homoannular
210 nm 215 nmn

a b)
245 nm d) 253 nm.

c)
spectrum the region 600-

ix) In a typical infrared (IR)
1400 cm-l is known as
a) Complex splitting region
b) Fingerprint region
c) Unsymmetrical region
d) Stretching region.
3 Turn over
MPH-95365
[
x) Telsa is a unit of
a) Chemical shift
b) Precisional frequency
c) Resonance
d) Megnetic flux density.
xi) Mass spectrometer separates isotopes of different
elements based on their
a) Mass
b) Electric charge
c) Mass divided electric charge
d None of these.
xii) Which of the following unclei possesses magnetic
moment ?
a) D b) O
d) 16 S
GROUP- B
(Short Answer Type Questions )
Answer any three of the following. 3 x 5 15
Define chemical shift. What is its unit ? What is the

2.
effect of electronegativity on Chemical shift ? 1+1+3
MPH-95365 4
3. i) Define.
a) Bathochromic & Hypsochromic shift
b) Hyperchromic effect & Hypochromic effect
c) Chromophore & Auxochrome

Which of the isomers of Pentadiene (a) & amp; (b) =
ii)
absorbtion ?
will show longest wavelength of UV
a) CH2 = CH-CH=CH-CH3
-CH=CH2 3 +2
b) CH2 = CH-CH2
with
elution and isocratic elution
4. Define gradient
5
example. What is reverse phase chromatography.
and anaphoresis.
5. Define and differentiate cataphoresis
the instrumentation needed for capillary

Bricfly describe
2+3
with proper labeled diagram.
electrophoresis
Interference in FTIR.
6. Write short notes on Michelsons
GROUP- C
)
(Long Answer Type Questions
3x 15 = 45
Answer any three of the following.
5+5+5
7. Describe the following:
shift in proton NMR Spectroscopy

i)
Chemical
MPH-95365
5 [ Turn over
CS/M.PHARM/ODD/SEM-1/MPT-106 1/2017-18
ii) Different fundamental vibrations in IR

spectroscopy
ii) Nitrogen rule and McLafferty rearrangement.
8. a) What is the difference lies between normal phase
chromatography and reverse phase chromatography ?

b) What doyou mean by Ci8 columna?
c What is the application of HPLC in pharmaceutical
field?
d Write down the working diagram of one ideal HPLC

instrument. 5 + 2+ 4 + 4
9. State the procedure for

preparation of solid sample to
study in IR spectrophotometer. What is the utility of
Fingerprint' region ? Discuss the application of IR
spectroscopy in organic chemistry. What is Hook's law
and its applicability ? What is FT-IR ? Explain its
operational advantages. 4+4+3 +3

10. Write in detail on the principle, instrumentation and
application of Mass spectroscopy. 15
MPH-95365 6
11. Define and classily Electrophoresis. Write about the
theory and factors influencing electrophoresis. Explain
any two of the following methods
i) Paper Electrophoresis
i) SDS-PAGE
ii) Isoelectric Focusing. 2 +3 + 5+5
MPH-95365
Maulana Abul Kalam Azad Unversity
of
Tochnology,
West Bengal
Utech
OF
MAULANA ABUL KALAM AZAD UNIVERSITY
MODERN PHARMACEUTICS
70
TimeAllotted: 3 Hours Full Marks:
The figures in the margin indicateful marks.

in their own
Candidates are required to give their answers
GROUP-A
(Multiple Choice Type Questions )
ten of the
Choose the correct alternatives for any
1.
10 x 1 10 =
following
formed due to addition
i Lyotropic liquid crystals are
of
a) Humectant b Surfactant
Solvent d) Polymer.
c)
the concept of
of 1CH provide
ii Which guidelines
QbD ?
ICH Q1 b) ICH Q3
a)
d) ICH Q7
c) ICH Q8
Turn Over
MPH-95379
drug is a
ii) Photochemical degradation of multisulpha
order reaction.
zero b) first
a)
c pseudofirst d) second.
is order of
iv) Hydrolysis of ester
degradation.
a) zero b) pseudo zero
c) pseudofirst d) second.
v Unit of rate constant for first order rate kinetics is
a) Itimej
b) [concentration/time]
-1
c concentration.time]
d none of these.
The in involving small

vi process compression
particles to deform plastically is
a) Microsquasing
b) Brittle fracturec
c Plastic deformation
d) Elastic deformation.
MPH-95379 2
of the following methods to determine the

vii
Which
concept ?
surface tension based on Young Laplace
a) Stalagmometer
method
b) Capillary rise
c) Ring method
d) None of these.
in
...% dissolution
vii In immediaterelease
ensure that the
can
0-1N HCI in 15 minutes
not limited by
is
of the drug
bioavailability
dissolution.
b) 50
a) 100
d) 25.
c)
85
Flow is
1x) Pseudoplastic
b) Shear thickening
Flow
a Newtonian
d) None of these.
c)
Shear Thinning
is
Viscosity
x)Unit of Kinematic
b
b) MilliPascal.Sec
a) Dynes/cm
d) Poise.
c) Stoke
over
Turn
3
MPH-95379
xi Determination of true volume is done by
a) Mercury Displacement
b) Fisher Sub Sieve
Quntasorb
d) Helium Pycnometer.
XI1) s: y tor spherical particle
a) 61 b) 1:6
c) 1:5 d) 4 1.
GROUP B
Answer any three of the following. 3 x 5 = 15
2 Apply test to find the efficacy of tablet from the data
given in the following table.
(Table value at p = 0-05 is 3.841)
Group Died Survived

Control on 10 25
placebo
Experiment 5 60
on tablet
3. How cGMP helps in boosting pharmaceutical export
opportunitices ? Define the coverage area of cGMP. 3+2

MPH-95379
4. Deline pre-formulation. Outline the principal arcas ot
pre-formulation. Write a note on polymorphism.I t °

its
5. Explain the rheological behaviour of an antacid and
role in providing physical stability.
a What do you understand by

6. Deline Factorial design.
? 2+3
3 factorial design
GROUP- C
(LongAnswer Type Questions) 3 x 15 = 45
? Elaborate
fusion bonding
7. What are cold welding and
solids.
lor compressed
the stages of compression
bed during
through powder
Distribute forces
of Heckle plots.
Define the significance
compression.
2 +5+ 5+3
of the
Give a schematic
Define pre-formulation. the
8. a)
illustrating
of pre-formulation
various stages
each stage.
studies under
most important
Study
Accelerated Stability
discuss the
b Bricfly
in formulation development.
and its importance
(1 +6)+ (6+2)
Turn Over
MPH-95379
9. a) The following table prescnt the mean cumulative
weight loss in grams for 12 patients receiving
formulation A and for 11 patients for receiving
formulation B. Do the data present sufficient
cvidence to conclude that the mcan cumulative

weight loss is different in two groups ? (unpaired
t-test). Table value of t is 2:831.
n Mean weight SD
loss
in mg
Formulation A 12 120 10
Formulation B11 70 8
b) What are type I error and Type II error ? 10+5
10. a) Twelve tablets are available for the comparison of
three assay methods, four tablets for each assay
(ANOVA). The recorded results in mg were as
follows
1st Method 2nd Method 3rd Method

25 20 24
22 17 26
24 16 30
21 19 20
if value at degree of freedom (2, 9) at 5% level is
4-26, is there any differcnce in cach assay ?
MPH-95379 6
b)
b) Define null
hypothesis. Define alternative
hypothesis. What is their significance in
statistical
analysis?
10+(2,+2
11. Explain different method
of Processes validation in case
of
parenteral product with
proper example.
12. Explain The importance of
qualification in validation.
Explain the following term:
DO, 10, OQ, PQ.
MPH-95379
5eoPy SCHOOL
LIBRARY
ANDHA
MaulanaAbul KalamAzad Unversty
c TechnologyWestBenga
Utech

MODERN PHARMACEUTICS
TimeAllotted: 3 Hours Full Marks:70
The figures in the margin indicatefull marks.
words as far as practicable.
GROUP- A
(Multiple Choice Type Questions)
Choose the correct alternatives for any ten of the
1.
10x 1 = 10
followingS:
formed due to addition

i) Lyotropic liquid crystals are
of
Humectant Surfactant
a)
c Solvent d) Polymer.
Which of ICH provide the concept of

ii guidelines
QbD?
a) ICH Q1 b) ICH Q3
d) ICH Q7
c)ICH Q8
MPH-95379 urn over
CS/M.PlHARM/ODD/SEM-1/MPT-1063/2017-18
is a
iii) Photochemical degradation of multisulpha drug
... order reaction.
a) Zero b) first
c)pseudofirst d) sccond.
iv Hydrolysis of ester 1S order of
degradation.
a Zero b) pseudo zero
c)pscudofirst d)sccond.
v Unit of rate constant for first order rate kinetics is
a) time
b) concentration/time]
c)concentration.time] -
d) none of these.
vi The procesS in
Compression involving small
particles to deform plastically is
a) Microsquasing
b) Brittle fracture
c) Plastic deformation
d) Elastic deformation.
MPH-95379 2
vii) Which of the
following methods to determine the
surface tension
based on Young Laplace concept
a)
Stalagmometer
b)
b) Capillary rise method
c) Ring method
d) None of these.
vii) In immediate release ..% dissolution in
01N HC in 15 minutes can ensure that the
bioavailability of the drug is not limited by
dissolution.
a) 100 b) 50
c 85 d) 25.
ix) Pseudoplastic Flow is
a) Newtonian Flow b) Shear thickening
Shear Thinning d) None of these.

c)
is
Unit of Kinematic Viscosity
b) MilliPascal.Sec
a) Dynes/cm
Stoke d) Poise.
c)
MPH-95379
3 Turn over
[
CS/M.PHARM/ODD/SEM-1/MPT-1063/2017-18S
done by
of true volume is
xi) Determination
a)Mercury Displacement
b) Fisher Sub Sieve
c) Quntasorb
d) Helium Pycnometer.
xii) a:a,for spherical particle is
1:6
a 6:1 b)
1:5 4:1.
c d)
GROUP B
3x 5 15
the from the data

2. test to find efficacy of tablet
Apply
given in the following table.
at p = 0:05 is 3.841)
(Table value
Died Survived
Group
10 25
Control on
placebo
60
Experiment
on tablet
3. How cGMP helps in boosting pharmaceutical export
opportunities ?Deline the coverage area of cGMP. 3+2

MPH-95379
4. Define CS/M.PHARM/ODD/SEM-1/MPT-1063/2017-18
pre-tormulation. Outline
the
principal areas ol
pre-formulation. Write a
note on 1 + +3
polymorphism.1
5. Explain the
rheological behaviour of
an antacid and 1ts
role in
providing physical
stability.
6. Define a Factorial
design. What do you
understand by
3 factorial design?
2 +3
GROUP-C
Answer any =45
three of the
following. 3x 15
7. What are cold welding and fusion bonding ? Elaborate
the stages of for compressed
compression solidS.
Distribute forces bed

through powder during
compression. Define the significance of Heckle plots.
2+5 5 +3
8. a) Define pre-formulation. Give a schematic of the
various stages of pre-formulation illustrating the
most important studies under each stage.
Accelerated
b) Bricfly discuss the Stability Study
and its importance in formulation development.
(1+6)+ (6 + 2)
MPH-95379 5 Turn Over
CS/M.PHARM/ODD/SEM-1/MPT-1063/2017-18the mean cumulative
prescnt
9. a) The following table
receiving
for 12 patients
loss in grams
Weight for receiving
A and for 11 patients
1ormulation
sufficient
present
B. Do the data
formulation
the mean cumulative
evidence to conclude that
two groups
? (unpaired
is different in
weight loss
is 2:831.
t-test).
Table value of t
Mean weight loss SD

n
in mg
Formulation A | 12 120 10
Formulation B 11 70
error 10 +5
What are type I error and Type ll
b)
ot
for the comparison
10. a) Twelve tablets are available
four tablets for
each assay
three assay methods,
were as
The recorded results in mg
(ANOVA).
follows
1st Method
25
|
2ndMethod
20
3rd Method
24
17 26
22
24 16 30
21 19 20
if value at degree of freedom (2, 9) at 5% level is
4-26, is there any difference in each assay ?
6
MPH-95379
b) Deline null Define alternative

hypothesis.
in
hypothesis. What is their significance
statistical analysis ? 10(2+2

in case
11. Explain diffcrent method of Processes validation
of parenteral product with proper example.
in validation
The importance of qualification
12. Explain
Explain the following term
DQ, 1Q, O0, PQ.
MPH-95379
Madlana Abul KalamAzad Uhiersdy
d Techeology, West Bengal
Utech

Paper
DRUG DELIVERY SYSTEM
Code MPT-1062 :
3
TimeAllotted: Hours Full Marks:
70
The figures in the margin indicate full marks.
in their own
Candidates are required to give their answers
words asfar aspracticable.
GROUP- A
ten of the
1. Choose the correct alternatives for any
10x 1 = 10
following:
i) Melting point
of solid hydrocarbon for ophthalmic
ointment is
b) 34'C
a) 37'C
25°C.
c) 40C d)
be
ii) Nanomicelles for ocular delivery should
a) hydrophobic
b) hydrophilic
c) None of these.
Turn
I
MPH-95370
.PHARM/ODD/SEM-1 /MPT-1062/2017-18
m) Oral bioavailabilityof protein drug can be increased

by
b) Protein Lipidizationa
c) Use of Vit. B12
d) Both (b) and
(c)
iv) In TDDS drug ultimately reach to
a) Epithelial layer b) ntracellular layer
c) Dermal layer d)Systemic circulation.
v Which of the following ingredients can be used as
an encipient to prepare colon targeted controlled
release drug
delivery system?
a) Crospovidone
b) Pectin
c) Lactose
d) None of these.
vi) The intensity of current flow normally used for
intophoretic transdermal drug delivery system is
a) 5A/cm2 b) 25 mA/cm
c) 500 mA/cm2 d) none of these.
vii) Transderm Nitro' is an example of
a) Polymer membrane
permeation controlled DDS
b) Polymer matrix diffusion controlled DDS
c) Microreservoir partition controlled DDS
d) Enzyme activate DDS.
viii) 'Alzet'osmotic pump is a/an
a) injectable formulation
b) implantable formulation
c) oral formulation
MPH-95370 2
ix) For controlled release drug delivery system, if the

rate constant of drug release is K, and drug
absorption is K,, then

a) K, >> Ka b) K, <« Ka
c) K, =Ka d) none of these.
are subjected to
x Which of the following drugs
intestinalmetabolism?
a) hydralazine b) salicylamide
d) all of these.
c) nitroglycerine
NLCs, Dissocubes and SLNs are examples of
xi)
c) surfactant aggregates
a) site specificdrug delivery systems
b) localized drug delivery systems
c) implantable drug delivery systems

d) targeted drug delivery systems.
GROUP- B
Answer any three of the following. 3 x 5 15
2. Write a short note on principles of self regulated device
3. What are different barriers in drug permeation of ocular
drug delivery ? Explain brielly.
4. What is pharmacogenetics and 3D printing of
pharmaceuticals.
2+
ol drug Irom
releasc kinctics
5. Derive the equation of
deviccs.
diffusion controlled matrix type and pka of
of solubility
6. DIscuss on importance aqucous
a drug oral controlled relcase delivery.
GROUP-C
guestions)
(LongAnswer Type 3x 15 = 45
Answer any three of the folowing.
in novcl
of liposomes
7. a) Discuss the special status
drug delivery.
the limitations
Mention with suitable explanations
b
of liposomes.
with suitable
Bio-adhesive polymers
8. a) Classify the
mucoadhesion ?
b) What are the factors affecting the
of TDDS. Properly explain
9. Explain the different features 5+ 10
TDDS development and evaluation methods
:
10. Write short notes on any two of the following
a) pH activated drug delivery system

of Vaccine delivery system.
11. Explain the difliculties
Explainthe delivery of vaccine through mucosal and
transdermal delivery. 5+5+5
4
MPH-95370
Mauana Abul KalamArad
Unversity
Techoloy,West
od
Bengal
Utech
tnavag
A
MAULANA ABUL KALAM AZAD UNIVERSITYODF
Paper Code MPT-1062
DRUG DELIVERY SYSTEM
TimeAllotted 3 Hours Full Marks 70
Thefigures in the margin indicatefullmarks.

GROUP -A
the alternatives for any ten of the

1. Choose correct
following:
10 x 1
= 10
for ophthalmic
i) Melting point of solid hydrocarbon
ointment is
a) 37C b) 34C
c) 40C d) 25'C.
Nanomicellesfor ocular delivery should be

ii)
a) hydrophobic
b) hydrophilic
c) None of these.
Turn over
I
MPH-95370
CS/M.PHARM/ODD/SEM-1/MPT-1062/2017-18 be increased
of protein drug can
u) Oral bioavailability
by
b) Protein Lipidization
c) Use of Vit. B12

d) Both (b) and (c).
reach to
iv) In TDDS drug ultimately
Intracellular
layer
b)
a) Epithelial layer círculation.
d) Systemic
c) Dermal layer can be used as
ingredicnts
v Which of the following colon targeted
controlled
an encipient to prepare
release drugdelivery systenm?
a Crospovidone
Pectin
b)
c) Lactose
d) None of these. used for

of current flow normally
vi) The intensity system is
transdermal drug delivery
intophoretic
b) 25 mA/cm
a) 5A/cm
d) none of these.
c) 500 mA/cmn2
of
Transderm Nitro'is an example
vii)
controlled DDS
a) Polymer membrane permeation
diffusion controlled DDS
b) Polymer matrix
DDS
c) Microreservoir partition controlled
d) Enzyme activate DDS.

is a/an
viii) 'Alzet' osmotic pump
a) injectableformulation
b) implantable formulation
c) oral fornmulation
MPH-95370
2
ix) For controlled release drug delivery system, if the

rate constant of drug release is K, and drug
absorption is K,, then

a) K, Ka b) K, << Ra
c) K, - Ka d) none of these.
X Which of the following drugs are subjected to
intestinalmetabolism ?
a) hydralazine b) salicylamide
d) all of these.
c) nitroglycerine
SLNs are examples of
xi) NLCs, Dissocubes and
c) surfactant aggregates
a) site specific drug delivery systems
b) localized drug delivery systems
c) implantable drug delivery systems
d) targeted drug deliverysystemns.
GROUP- B
(Short AnswerType guestions)
Answer any three of the following. 3x 5 = 15
2. Write a short note on principles of self regulated device
3. What are different barriers in drug permeation of ocular
drug delivery ?Explain briefly.
4. What is pharmacogenetics and 3D printing of
pharmaceuticals.
MPH-95370 3 I Turn over

5. Derive the cquation of release kinetics of drug iron

diffusion controlled matrix type devices.
or
6. Discuss on importance of aqucous solubility and pKa
a drug oral controlled release delivery.
GROUP -C
(LongAnswer Type Questions)
Answer any three of the following. 3x 15 45 =
7. a) Discuss the special status of liposomes in novel
drug delivery.
b) Mention with suitable explanations the limitationsS
of liposomes.
8. a) Classify the Bio-adhesive polymers with suitable

b) What are the factors affecting the mucoadhesion ?
9 Explain the different features of TDDS. Properly explain
TDDS development and evaluation methods. 10 5+
10. Write short notes on any tuo of the following:
a) pH activated drug delivery system

I1. Explain the difficulties of Vaccine delivery systo
Explain the delivery of vaccine through mucosal and

transdermal delivery. 5+5 + 55
MPH-95370 A

Regulatory: Kalam OF West

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Cs/M.

MAULANA ABUL KALAM AZAD UNIVERSITY OF

1. Choose the correct alternatives for any ten of the

i Orange book is published in every year by

a) Govt. of India b) Govt. of Canada

a) New Drug Advertisement

b) New Delhi Drug Administration

c) New Drug Administration

d) New Drug Application.

i) Hatch-Waxman Act deals with

a) Generic drugs b) Branded drugs

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

iv) cGMP regulation related to food additives comes

a) 21 CFR 170 - 199 b) 21 CFR 200 299

c) 21 CFR 300 499 d) 21 CFR 500 599.

v) A capsule filling machine is purchased. What kind

ofqualification should be performed at first?

c) Concurrent d None of these.

vi In which of the following conditions an IND is not

indication established already

b) Intended only for in vitro or animal testing

c) Certain BA/BE studies-generic drugs

facts about the trial

conduct the trial with

the least hazard to patients.

b) Code of Federal Regulations

c) Cross Reference Letter

a) Unidirectional flow of materials

same area for different

Multidirectional flow of material

MPH-95383 3 [ Turn over

ix) Purified water shall meet the microbiological

x The current edition of cGMP contains

xi) 21 CFR is updated on

a January 1st of every year

b) March 31st of every year

c) April 1st of every year

d) December 31st of every year.

5. Write on the in-vitro assessment technique of

6. Give the key

BA and BE study to CRO.

MPH-95383 5 [Turn over

b) When is an IND required?

c) What are the essential principles of an IND ?

d) What are the standard contents of an initial

8. Explain any three of the following: 3x 5

a) Investigators Brochure (IB)

b) Institutional Review Board (IRB)

c) Clinical Research Organization (CRO)

d) Code of Federal Regulations 21 (CFR-21).

9. What is new drug development process ? What is its

importance ? Give a brief review on 'New Drug Approval

Process Regulatory requirement' in USA ? 3+3+9

USA. Give a brief review on IND application submission

11. What is Hatch-Waxnman Act ?What is its contribution

towards generic pharma companies ? Discuss the

requirements for filing ANDA. What is CFR ?

Maulana Abul KalamAzad Universty WDHA

MAULANA ABUL KALAM AZAD UNTVERSITY OF

i) Orange book is published in every year by

a Govt. of India b) Govt. of Canada

i) NDA is an abbreviated form of

a) New Drug Advertisement