Pharma Quiz # 4

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| By Swasp9

Swasp9

Community Contributor

Quizzes Created: 1 | Total Attempts: 96

Questions: 8 | Attempts: 96 | Updated: Mar 20, 2023

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Questions and Answers

1.

As per the Hatch-Waxman Act for Generics, Which certification is necessary to challenge an existing Patent?
- A.
  
  Para IV
- B.
  
  Para I
- C.
  
  Para III
- D.
  
  Para II
Correct Answer
A. Para IV

Explanation
According to the Hatch-Waxman Act for Generics, Para IV certification is necessary to challenge an existing patent. This certification is filed by a generic drug manufacturer when they believe that the patent for a brand-name drug is invalid or will not be infringed upon by their generic version. By filing a Para IV certification, the generic manufacturer is essentially stating that they are challenging the patent and are seeking approval to market their generic drug before the expiration of the patent.

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2.

Validity period of ETA license in India is
- A.
  
  5 years
- B.
  
  3 Years
- C.
  
  1 year
- D.
  
  None of the above
Correct Answer
C. 1 year

Explanation
The validity period of an ETA (Electronic Travel Authorization) license in India is 1 year. This means that once an individual obtains an ETA, they can use it to travel to India for a period of 1 year from the date of issuance. After this period, the ETA will expire and the individual will need to apply for a new one if they wish to continue traveling to India.

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3.

Principle of Fluid energy mill is :
- A.
  
  Attrition
- B.
  
  Impact
- C.
  
  A & b
- D.
  
  None of the above
Correct Answer
C. A & b

Explanation
The principle of a fluid energy mill involves both attrition and impact. Attrition refers to the wearing down of particles through friction and collision, while impact refers to the forceful collision between particles. In a fluid energy mill, particles are suspended in a high-velocity gas stream, which causes them to collide with each other and with the walls of the mill. This combination of attrition and impact helps in reducing the size of the particles and achieving the desired particle size distribution. Therefore, the correct answer is a & b.

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4.

The phenomenon of increasing solubility of weak electrolyte and a non polar molecule by addition of water miscible solvent in which the drug has good solubility is
- A.
  
  Cosolvency
- B.
  
  Solubalisation
- C.
  
  Hydrotropy
- D.
  
  Complexation
Correct Answer
A. Cosolvency

Explanation
Cosolvency refers to the process of increasing the solubility of a substance by adding a water-miscible solvent in which the substance has good solubility. This phenomenon is commonly observed with weak electrolytes and nonpolar molecules. By adding a water-miscible solvent, the solute molecules are dispersed more effectively, leading to an increase in solubility. Cosolvency is often used in pharmaceutical formulations to enhance the solubility of poorly soluble drugs, improving their bioavailability and therapeutic efficacy.

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5.

A commonly used antioxidant for oil system is
- A.
  
  BHT
- B.
  
  Ascorbic acid
- C.
  
  Sodium metabisulphite
- D.
  
  None
Correct Answer
A. BHT

Explanation
BHT, also known as butylated hydroxytoluene, is a commonly used antioxidant for oil systems. It helps to prevent the oxidation of oils by reacting with free radicals and inhibiting the formation of harmful compounds. BHT is stable at high temperatures and can extend the shelf life of oils by preventing rancidity. Ascorbic acid and sodium metabisulphite are also antioxidants, but they are not as commonly used in oil systems as BHT. Therefore, the correct answer is BHT.

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6.

------------------------ is used to determine particle size by Gravity Sedimentation Method
- A.
  
  Friabilator
- B.
  
  Andreason's Apparatus
- C.
  
  Pycnometer
- D.
  
  None of the above
Correct Answer
B. Andreason's Apparatus

Explanation
Andreason's Apparatus is used to determine particle size by Gravity Sedimentation Method. This apparatus is specifically designed to measure the settling velocity of particles in a liquid medium. By measuring the time it takes for particles to settle under the force of gravity, the apparatus can determine the particle size distribution. This method is commonly used in various industries, such as pharmaceuticals and environmental sciences, to analyze the size distribution of particles in different substances.

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7.

In capsule formulation, fill weight is depended on :
- A.
  
  Density of the blend
- B.
  
  Size of the capsule
- C.
  
  Chemical structure of the drug
- D.
  
  A & b
Correct Answer
D. A & b

Explanation
The fill weight in capsule formulation is dependent on the density of the blend and the size of the capsule. The density of the blend affects how much of the blend can fit into the capsule, while the size of the capsule determines the maximum amount of blend that can be filled. Therefore, both factors, a (density of the blend) and b (size of the capsule), contribute to determining the fill weight in capsule formulation.

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8.

DCG(I) approval for a Fixed Dose combination is not required if
- A.
  
  Not marketed in India & one or more active ingredient(s) is a new drug not approved in India
- B.
  
  Marketed in India but some changes are sought
- C.
  
  Not marketed anywhere but individual components used concomitantly
- D.
  
  Approved Drug combination exists in market
Correct Answer
D. Approved Drug combination exists in market

Explanation
If an approved drug combination already exists in the market, then DCG(I) approval for a Fixed Dose combination is not required. This means that if a combination of drugs has already been approved and is available for use, there is no need for additional approval for a similar combination.

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Current Version
Mar 20, 2023

Quiz Edited by
ProProfs Editorial Team
Jul 04, 2012

Quiz Created by
Swasp9

Pharma Quiz # 4

As per the Hatch-Waxman Act for Generics, Which certification is necessary to challenge an existing Patent?

Validity period of ETA license in India is

Principle of Fluid energy mill is :

The phenomenon of increasing solubility of weak electrolyte and a non polar molecule by addition of water miscible solvent in which the drug has good solubility is

A commonly used antioxidant for oil system is

------------------------ is used to determine particle size by Gravity Sedimentation Method

In capsule formulation, fill weight is depended on :

DCG(I) approval for a Fixed Dose combination is not required if