Industrial Pharmacy: Principles and Applications in Drug Development and Manufacturing

Question 1

Which technique is used to assess the stability of a drug product by exposing it to extreme conditions?

Accepted Answer

Accelerated stability testing

Answer

Thin-layer chromatography

Answer

Animal testing

Answer

Clinical trials

Question 2

During the pre-formulation phase of drug development, which step is crucial for determining the drug's physical and chemical properties?

Accepted Answer

Assessment of API solubility and stability

Answer

Identification of the active pharmaceutical ingredient (API)

Answer

Selection of the appropriate dosage form

Answer

Development of analytical techniques

Question 3

The main purpose of pre-formulation studies is to:

Accepted Answer

Identify the optimal dosage form for a drug

Answer

Determine the stability of a drug substance

Answer

Determine the pharmacokinetics of a drug

Answer

Evaluate the safety and efficacy of a drug

Question 4

The primary objective of clinical trials is to:

Accepted Answer

Determine the safety and efficacy of a drug

Answer

Identify the optimal dosage form

Answer

Establish the pharmacokinetic profile of a drug

Answer

Evaluate the stability of a drug

Question 5

GMP is an acronym for:

Accepted Answer

Good Manufacturing Practices

Answer

General Medicines Protocol

Answer

Good Medical Procedures

Answer

General Manufacturing Principles

Question 6

Which of the following is NOT a stage involved in bringing a new drug to market?

Accepted Answer

Sales and marketing

Answer

Pre-formulation

Answer

Clinical trials

Answer

Manufacturing

Question 7

What is the primary responsibility of the Quality Assurance (QA) department within the pharmaceutical industry?

Accepted Answer

Ensuring compliance with regulatory standards and guidelines

Answer

Overseeing product development and manufacturing processes

Answer

Conducting clinical trials to evaluate drug safety and efficacy

Answer

Marketing and selling pharmaceutical products

Question 8

Quality control in the pharmaceutical industry is responsible for:

Accepted Answer

Ensuring the safety and efficacy of drug products

Answer

Minimizing production costs

Answer

Developing new drug formulations

Answer

Providing customer support

Question 9

Which of the following is NOT a type of pharmaceutical excipient?

Accepted Answer

Antibiotics

Answer

Binders

Answer

Solvents

Answer

Lubricants

Question 10

In the United Kingdom, the regulatory authority responsible for drug approval is:

Accepted Answer

Medicines and Healthcare products Regulatory Agency (MHRA)

Answer

Food and Drug Administration (FDA)

Answer

European Medicines Agency (EMA)

Answer

National Institute for Health and Care Excellence (NICE)

Question 11

Generic drugs differ from brand-name drugs in that:

Accepted Answer

They may differ in inactive ingredients

Answer

They have different active ingredients

Answer

They are always less effective

Answer

They are not subject to the same regulatory approval process

Question 12

Which of the following is NOT a key aspect of Good Manufacturing Practice (GMP)?

Accepted Answer

Cost-cutting measures

Answer

Documentation and record-keeping

Answer

Equipment qualification and validation

Answer

Personnel training and qualification

Question 13

What is the main responsibility of a formulation scientist in the pharmaceutical industry?

Accepted Answer

To design and develop drug delivery systems to enhance drug efficacy and safety.

Answer

To conduct clinical trials to evaluate the safety and efficacy of drug candidates.

Answer

To ensure the quality of drug products by monitoring manufacturing processes.

Answer

To market and sell drugs to healthcare professionals and patients.

Question 14

What is the primary objective of a process validation study in pharmaceutical manufacturing?

Accepted Answer

To demonstrate that a manufacturing process consistently produces a product that meets pre-defined quality specifications.

Answer

To identify potential sources of error and variability in the manufacturing process.

Answer

To establish optimal operating parameters for the manufacturing process to ensure consistent product quality.

Answer

To develop new and innovative manufacturing technologies to improve efficiency and productivity.

Question 15

Which type of packaging is most commonly used for solid oral dosage forms, such as tablets and capsules?

Accepted Answer

Blister packs, providing individual protection and easy dispensing.

Answer

Bottles, offering convenience and cost-effectiveness for larger quantities.

Answer

Pouches, suitable for flexible packaging and extended shelf life.

Answer

Tubes, ideal for semi-solid or liquid dosage forms requiring precise dosing.

Question 16

What is the primary route of administration for most injectable drugs?

Accepted Answer

Intravenous injection, delivering drugs directly into the bloodstream for rapid onset of action.

Answer

Intramuscular injection, administering drugs into muscle tissue for sustained release and absorption.

Answer

Subcutaneous injection, injecting drugs beneath the skin for slower absorption and localized effects.

Answer

Intradermal injection, introducing drugs into the skin's upper layers for local anesthesia or allergy testing.

Question 17

Which of the following is a potential adverse event associated with the use of solid oral dosage forms?

Accepted Answer

Gastrointestinal irritation, including nausea, vomiting, or abdominal discomfort.

Answer

Allergic reactions, ranging from mild skin rashes to severe anaphylaxis.

Answer

Cardiovascular toxicity, affecting heart rate, blood pressure, or cardiac function.

Answer

Neurological disorders, such as seizures, tremors, or dizziness.

Question 18

Which of the following factors is NOT typically considered during pre-formulation studies for a new drug?

Accepted Answer

Patient compliance

Answer

Particle size

Answer

Solubility

Answer

Stability

Question 19

A pharmaceutical company is developing a new tablet formulation. Which manufacturing process is most likely to be used?

Accepted Answer

Direct compression

Answer

Lyophilization

Answer

Spray drying

Answer

Microencapsulation

Question 20

What is the primary objective of quality control in pharmaceutical manufacturing?

Accepted Answer

Ensuring product consistency and safety

Answer

Maximizing production yield

Answer

Developing new drug formulations

Answer

Minimizing production costs

Question 21

Which of the following is a crucial aspect of post-marketing surveillance of a new drug?

Accepted Answer

Pharmacovigilance

Answer

Clinical trials

Answer

Pre-clinical studies

Answer

Manufacturing process optimization

Question 22

What is a potential disadvantage of reformulating an existing drug?

Accepted Answer

Increased risk of side effects

Answer

Extended drug release

Answer

Improved bioavailability

Answer

Enhanced patient compliance

Question 23

Which type of stability testing focuses on evaluating the impact of temperature on a drug formulation?

Accepted Answer

Temperature stability testing

Answer

Humidity stability testing

Answer

Light stability testing

Question 24

Which method is commonly used to assess the rate at which a drug dissolves from its formulation?

Accepted Answer

Dissolution testing

Answer

Stability testing

Answer

Bioavailability studies

Answer

Microscopy

Question 25

Which of the following phases is NOT a standard phase in clinical trials for a new drug?

Accepted Answer

Phase 0

Answer

Phase 2

Answer

Phase 1

Answer

Phase 3

Question 26

Which regulatory body is responsible for approving new drugs in the United Kingdom?

Accepted Answer

The Medicines and Healthcare products Regulatory Agency (MHRA)

Answer

The European Medicines Agency (EMA)

Answer

The Food and Drug Administration (FDA)