A.K.T.U.

, Lucknow
Rajarshi Rananjay Sinh College of Pharmacy, Amethi
Maharaja Bhagwan Baksh Singh Nagar, Jangal Ramnagar,Amethi, Uttar Pradesh 227405
B. Pharm IV year VIII semester Even Sem. (2020-21)

Subject- Pharmaceutical Product Development Subject code- BP 813T

Q.1. Stages of Pharmaceutical Product Development do not include

a. Preclinical studies
b. INDA
c. GLP
d. NDA

Q.2. What is INDA

a. Introductory New Drug Approval
b. Investigational New Drug Approval
c. Inventive New Drug Approval
d. Innovative New Drug Approval

Q.3. Preclinical studies include

a. Preformulation study
b. Formulation Development
c. Drug Disposition study
d. All of the above

Q.4. Other name of Clinical Trail Phase II

a. Therapeutic Exploratory
b. Human micro dosing
c. Human Pharmacology
d. Therapeutic Confirmatory

Q.5. Confirmatory trial relates to

a. Clinical trial Phase I
b. Clinical trial Phase II
c. Clinical trial Phase III
d. Clinical trial Phase IV

Q.6.Which of the following substances having poor water solubility

a. Weak electrolytes
b. Non polar molecules
c. Both
d. None
Q.7. Which one of the following is not true
a. Drugs can be hydrophilic or hydrophobic
b. Hydrophobic drugs are easily wetted
c. Hydrophobic drugs have low solubility in water
d. Hydrophobic drugs dissolve slowly
Q.8. Which property measures the resistance of a liquid to flow
a. Density
b. Viscosity
c. Volume
d. Solubilty
Q.9. Rate of dissolution equation given by
a. Noyes-Whitney
b. Larned B. Asprey
c. Marcellin Berthelot
d. Stephen L. Buchwald
Q.10. pKa is
a. Association constant
b. Dissociation constant
c. Ionization constant
d. Other
Q.11. ICH stands for
a. Indian Council for Hormonization
b. Indian Conference of Hormonization
c. International Council for Hormonization
d. International Conference for Hormonization
Q.12. pH stands for
a. Hydrogen ion concentration
b. Acid concentration
c. Base concentration
d. Other
Q.13. Full form of API is
a. Action Pharmaceutical Ingredient
b. Active Pharmacy Ingredient
c. Active Pharmaceutical Ingredients
d. Active Pharmaceutical Investigation
Q.14. Full form of CFR
a. Code of Federal Regulation
b. Center of Federal Regulation
c. Code of formulation Regulation
d. Code of Federal Responsibility
Q.15. FDA means
a. Food and Drug Application
b. Food and Drug Administration
c. Food and Development Administration
d. Food and drug Association
Q.16. As per ICH guidelines the sub-section Q1A deals with
a. Photo stability testing
b. Stability testing of new dosage forms
c. Evaluation of stability data
d. Stability testing of new drugs and products
Q.17. For accelerated stability studies as per ICH guidelines with storage condition as Refrigerated
condition the testing condition is
a. 10oC & 50% RH for 6 months
b. 25 oC & 60% RH for 6 months
c. 5 oC for 12 months
d. 40 oC & 75% RH for 2 days
Q.18. The temperature of cold rooms is
a. 2 oC to 5 oC
b. 2 oC and 8 oC
c. 0 oC to 10 oC
d. 5 oC to 10 oC
Q. 19. Disintegration time for sugar coated tablet is
a. 15 min
b. 60 min
c. 30 min
d. 5 min
Q. 20. Weight variation limits for more than 250 mg of tablet, as per IP
a. ± 7.5%
b. ± 2.5%
c. ± 5 %
d. ±10%
Q. 21. Choose the correct sequence for manufacturing of hard gelatin capsule shell
a. Dipping-Spinning-Stripping-Drying-Trimming-Joining-Polishing
b. Drying- Dipping-Spinning-Stripping- Trimming-Joining-Polishing
c. Dipping-Spinning- Drying - Stripping- -Trimming-Joining- Polishing
d. Drying- Spinning- Dipping-Stripping- Trimming-Joining-Polishing
Q. 22. Limit for friability test of tablet is
a. 0.5%-1%
b. More than 1%
c. 1-2%
d. More than 2%
Q. 23. Which of the following is not a method of soft gelatin capsule preparation?
a. Rotary die process
b. Accogel method
c. Fushion method
d. Plate process
Q. 24. Which of the following is not a manufacturing method for semi solid preparations?
a. Fushion method
b. Levigation method
c. Trituration method
d. Granulation method
Q. 25. Which of the following formulations would not be applicable to ocular administration?
a. Solution
b. Liniment
c. Suspension
d. ointment
Q. 26. Which of the following is a test for evaluation of suppositories?
a. Melting point
b. Freezing point
c. Solidification test
d. Drying point
Q. 27. What should be the value of sedimentation volume for an ideal suspension?
a. Less than 1
b. Greater than 1
c. 1
d. None
Q. 28. Solute is not dissolved when it is added to
a. Solvent
b. Solution
c. Mixture
d. Reaction
Q. 29. Aqueous solution includes
a. Salt solution
b. Sugar solution
c. Mineral water
d. All of them
Q. 30. Which of the following statements is Not true about Cyclodextrins?
a. They are polysaccharides
b. They are useful for formulating hydrophobic APIs
c. They have a hydrophilic outer surface
d. They are useful for formulating hydrophilic APIs
Q. 31. ____________ are surface-active agents that aggregate near or have a strong effect on modifying
the interface b/w two materials.
a. Carboxylate
b. Tween
c. Ampholytic elements
d. Surfactants
Q. 32. The hydrophilic moiety may be anionic, cationic, ampholytic, or non-ionic not depending on the
type of charge(s) carried, if any
a. True
b. False
Q. 33. The Span materials tend to be less water soluble than the __________ materials. The same material
could be a detergent, and a wetting agent
a. Carboxylate
b. Tween
c. Ampholytic elements
d. Surfactants
Q. 34.Which of the following is the industrial method of formation of glycol
a. Hydroxylation of alkene by Bayer’s reagent
b. From 1,2- dibromoethane
c. Oxidation of ethylene and using Ag as catalyst
d. Ethylene treatment with HOCl
Q. 35. Which of the following is not a method of preparation of glycol?
a. Shell’s omega method
b. From carbon monoxide
c. From Dimethyl oxalate
d. From nitrogen
Q. 36. Suspended particles become flocculated in a suspension, because
a. Particles are closely packed
b. Attractive forces between particles are appreciable
c. Repulsive forces between particles are appreciable
d. Vehicle rejects the particles
Q. 37. Brownian movement of particle_______________ sedimentation

a. Assist
b. Promote
c. Prevent
d. Increase

Q. 38. The HLB system is used classify

a. Flavours
b. Colours
c. Surfactants
d. Perfumes
Q. 39. An emulsifier is considered to be ideal, if it is soluble in

a. Aqueous phase
b. Oily phase
c. a&b
d. none of the above

Q. 40. Suspension of hydrophobic drug formulated with?

a. Emulsifying agents
b. wetting agents
c. suspending agents
d. All of the above

Q. 41. Which one of the following emulsifier is used to stabilize W/O emulsion

a. SLS
b. Span 20
c. Tween 20
d. Tragacanth

Q. 42. Which of the following is not a semisolid dosage form?

a. Suspension
b. Creams
c. Ointments
d. Paste

Q. 43. Which of the following fatty acid used in water removal creams as emulsifier?

a. Stearic acid
b. Palmitic acid
c. None
d. Both a & b

Q. 44. Benzalkonium chloride is categorized as

a. Quaternary ammonium compounds

b. Neutral preservative
c. Acidic preservative
d. Mercurial preservative

Q. 45. To increase the viscosity of liquid, which of the following agents are used

a. PVP
b. Methyl Cellulose
c. Sodium Carboxy methyl cellulose
d. All the above
Q. 46. Gum Arabic is a

a. Anionic polysaccharide
b. Neutral polysaccharide
c. Cationic polysaccharide
d. None

Q. 47. Which of the following is not used as an emulsifying agent?

a. Surfactant
b. Hydrophilic chloride
c. Electrolytes
d. Finely divided solids

Q. 48. The solubility of weak electrolyte and non-polar substances can be increased by adding water
miscible solvents. This process is known as

a. Co-solvency
b. Complexation
c. Both
d. None

Q. 49. Which of the following are widely used and excellent preservatives?

a. Mercurial
b. Quaternary ammonium compounds
c. Both
d. Acidic

Q. 50. Which of the following is lubricant?

a. Gum acacia
b. Magnesium stearate
c. Mannitol
d. HPMC

Q. 51. Direct compression defines the process by which tablets are prepared by

a. Compressing directly the powder blends of active ingredient/s and suitable excipients
b. Compressing after slug formation
c. Compressing after granule preparation
d. All of the above

Q. 52. Direct compression formulation can be developed without using

a. Diluents
b. Disintegrant
c. Lubricant
d. Antiadherent
Q. 52. Which of following is commonly used for direct compression?

a. Methyl cellulose
b. HPMC
c. Hydroxyl propyl cellulose
d. All

Q. 53. Spray-crystallized maltose-dextrose is also known as

a. Emdex
b. Dextrate
c. Lactitol
d. Nutab

Q. 54. Which of the following is the first excipient specially designed for direct compression?

a. TRI-CAFOS
b. Advantose 100
c. Fast flo lactose
d. Spray- dried lactose

Q. 55. Which of the following is free- flowing material that does not disintegrate?

a. Starch
b. Dicalcium phosphate dehydrate
c. Anhydrous β-lactose
d. Microcrystalline cellulose

Q. 56. Di-Pac is a derivative of

a. Sugar
b. Cellulose
c. Starch
d. Lactose

Q. 57. Avicel of which grade is having finest particle size?

a. PH101
b. PH102
c. PH105
d. PH 200
Q. 58.Which of the following polymer is widely used in film coating of tablets?
a. Acacia
b. Syrup
c. HPMC
d. Starch
Q. 59. Lamination is
a. Separation of a tablet into two or more distinct layers
b. Partial or complete separation of the crowns of a tablet from the main body of the tablet
c. Process of sub-coating of tablets
d. None of the above

Q. 60. Subcoating is given to the tablets

a. To avoid deterioration due to microbial attack

b. To provide the rapid buildup necessary to round up the tablet edge
c. To prevent the solubility of in acidic media
d. To avoid stickiness

Q. 62. Which of the following ingredients is used for polishing of sugar coated tablets?

a. Gelatin
b. Talc
c. PEG 4000
d. Carnauba wax

Q. 63. What happens in mottling defect of tablet?

a. Detachment of film from substrate

b. Areas of film are pulled away from the surface
c. Volcanic-like crates appears exposing tablet surface
d. Uneven distribution of the color on the surface of the tablet

Q. 64. Enteric coated tablets are designed to release drug in

a. Colon
b. Stomach
c. Intestine
d. Mouth

Q. 65. Which of the following commercially available product is used for sugar coating of tablets?

a. Opalux
b. Opaspray
c. Opadry
d. None of the above

Q. 66. A solvent that dissolves a lyophilized powder or dilutes a solution

a. Diluents
b. Solvent
c. Additive
d. Admixture
Q. 67. Injected into CSF

a. Intraperitoneal
b. Intravenous
c. Intracardiac
d. Intrathecal

Q. 68. In parenteral formulations, preservatives are required to be added in

a. Nonaqueous vehicle
b. Multiple dose containers
c. Single dose containers
d. All of the above

Q.69. Among the propellants used in aerosols one of the following is used for topical pharmaceutical
aerosols

a. Trichloro monofluoro methane’

b. Dichloro difluoro methane
c. Dichloro tetra fluoro ethane
d. Propane

Q. 70. The dip tube in aerosol container is made from one of the following

a. Polypropylene
b. Glass
c. Stainless steel
d. Aluminium

Q. 71. Simethicone is an example of

a. Wetting agent
b. Humectants
c. Antioxidant
d. Anti foaming agent

Q. 72. P11 is the code for which of the following propellant?

a. Trichloro monofluoro methane

b. Dichloro difluoro methane
c. Dichloro tetra fluoro ethane
d. Chloro fluoro methane

Q. 73. SR tablet should follow ______________ order of kinetics

a. First order kinetic
b. Zero order kinetic
c. Second order kinetic
d. None
Q. 74. What are the characteristics of the monolithic devices?

a. The drug has a large therapeutic index

b. Aqueous solutions
c. Control drug release by partitioning the drug from the oil
d. Administration of emulsions

Q. 75. In any experiment, the variable that is manipulated is called the

a. Independent variable
b. Dependent variable
c. Cofounding variable
d. Both a and b

Q. 76. Condition in which the formulator has to make hard tablet which should disintegrates within times
less than 20minutes, the problem is of which type?

a. Unconstraint
b. Constraint
c. Both
d. None

Q. 77. Higher the variables, _________________ are the complications.

a. Higher
b. Neutral
c. Lower
d. None of the above

Q. 78. Method in which calculus is used on problems is

a. Simplex method
b. EVOP method
c. Lagrangian method
d. Search method

Q. 79. In simplex method, if there are three variables what will be the shape of simplex?

a. Line
b. Triangle
c. Tetrahedron
d. Quadrilateral

Q. 80. Name the method that is used for solving problems in linear programming
a. Caronical analysis
b. Simplex method
c. Search method
d. Langrangian method
Q. 81. Search method comes under which of the following statistical design method

a. Simultaneous
b. Sequential
c. Both
d. None

Q. 82. Which method is also known as downhill method?

a. Simplex method
b. Basic simplex
c. Lagrangian method
d. Modified simplex

Q. 83. Response surface methodology is also called as

a. Sequential optimization
b. Surface optimization
c. Simultaneous optimization
d. None

Q. 84. Hadamard designs are another name for ________

a. Plackett – Burman
b. Taguchi
c. Latin square
d. Mixture

Q. 85. Factorial design is a________

a. Off-line quality control tool

b. On-line quality control tool
c. In-process procedure
d. Redundancy plan

Q. 86. Coding for two levels full factorial design will be

a. -1, +1
b. -1, 0
c. +1, 0
d. None

Q. 87. ANOVA stands for

a. Analysis of variance
b. Analysis of variables
c. Analysis of variety
d. None
Q. 88. What will be method of choice in case of situation having 2-4 factors?

a. Mixture design
b. Crossover design
c. Fractional factorial design
d. Full factorial design

Q. 89. An element of QbD that measures input and output material attributes of a process step is known as

a. Critical quality attributes

b. Target product profile
c. Critical process parameter
d. Control strategy

Q. 90. CMA stands for

a. Critical material attributes

b. Critical machine attributes
c. Critical mechanism attributes
d. Critical monitoring attributes

Q. 91. Cause – effect diagram is other name of

a. Ishikawa diagrams
b. Pareto chart
c. Shewhart charts
d. None

Q. 92. Risk analysis is a part of

a. Risk control
b. Risk assessment
c. Risk communication
d. Risk review

Q. 93. Process- behavior charts are also known as

a. Shewhart charts
b. Pareto charts
c. Both a and b
d. None

Q. 94. POS stands for

a. Problem operating space

b. Potential operating space
c. Public operating space
d. None
Q. 95. Choose odd from the following

a. Failure Mode effects Analysis

b. Hazard Analysis and Critical Control Points
c. Preliminary Hazard analysis
d. Process Analytical technology

Q. 96. Which is not an example of closure?

a. Crimp on
b. Shrink wrapper
c. Press on
d. Roll on

Q. 97. What is the other name of Type-II glass material?

a. Treated soda-lime glass

b. Regular soda-lime glass
c. Borosilicate glass
d. General purpose soda- lime glass

Q. 98. Which is not an example of thermosets material?

a. Phenol Formaldehyde
b. Poly propylenes
c. Melamine Formaldehyde
d. Epoxy resins

Q. 99. Powdered Glass test cannot be done for which type of glass material:

a. Treated soda-lime glass

b. Regular soda-lime glass
c. Borosilicate glass
d. General purpose soda- lime glass

Q. 100. Eye irritation test/ Rabbit test is done for which preparation

a. Parenteral preparation
b. Non-parenteral preparation
c. Ophthalmic preparation
d. None