Pharmaceutical Stability Studies

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What is the purpose of conducting long-term, intermediate, and accelerated stability studies?

To evaluate the physical, chemical, biological, and microbiological attributes of a drug product (correct)

To determine the preservative content of a drug product

To test the functionality of a metered-dose delivery system

To observe signs of product instability in pharmacy practice

What type of products have separate protocols for stability studies?

Chemical drug entities

Products destined for geographic areas of temperature extremes

Biotechnological/biological products (correct)

Products intended for refrigeration

How long do pharmaceutical manufacturers retain production samples of drug/drug product after FDA product approval and initial marketing?

3 years

10 years

1 year

5 years or longer (correct)

What is an example of a functionality test in stability studies?

Metered-dose delivery system test Signup and view all the answers

What is the responsibility of pharmacy practitioners in regards to stability studies?

Observing signs of product instability and reporting findings Signup and view all the answers

What is the purpose of conducting stability studies under various conditions of storage?

To observe signs of product instability under different storage conditions Signup and view all the answers

What is the purpose of studying the stability of drug products?

To predict the shelf life of a product Signup and view all the answers

What is a sign of drug instability in pharmaceutical formulations?

Change in physical appearance Signup and view all the answers

What factor influences the rate of chemical change in a drug product?

All of the above Signup and view all the answers

What is the first step in a kinetic study?

Measuring the drug's concentration Signup and view all the answers

Why is it important to study the rate of chemical change in a drug product?

To predict the shelf life of a product Signup and view all the answers

What is the purpose of varying the original conditions in a kinetic study?

To determine the influence of changes on drug stability Signup and view all the answers

What is the primary reason for using different stability test protocols for tablets or capsules packaged in glass or plastic bottles versus blister packs or strip packaging?

To accommodate differences in packaging materials Signup and view all the answers

What type of changes may indicate drug instability in pharmaceutical formulations?

Changes in physical appearance, color, odor, or taste Signup and view all the answers

What is a common strategy for stabilizing easily oxidizable drugs in pharmaceutical formulations?

Excluding oxygen, oxidizing agents, and trace metals Signup and view all the answers

What categories of chemical processes can contribute to drug instability?

Oxidation, hydrolysis, and deamination Signup and view all the answers

When is drug stability testing particularly critical?

During preclinical testing and clinical trials Signup and view all the answers

Why is drug stability assurance vital for a marketed drug product?

To ensure patient safety and product effectiveness Signup and view all the answers

Pharmaceutical Stability Studies

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