Podcast
Questions and Answers
What is the purpose of conducting long-term, intermediate, and accelerated stability studies?
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?
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?
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?
What is an example of a functionality test in stability studies?
What is the responsibility of pharmacy practitioners in regards to stability studies?
What is the responsibility of pharmacy practitioners in regards to stability studies?
What is the purpose of conducting stability studies under various conditions of storage?
What is the purpose of conducting stability studies under various conditions of storage?
What is the purpose of studying the stability of drug products?
What is the purpose of studying the stability of drug products?
What is a sign of drug instability in pharmaceutical formulations?
What is a sign of drug instability in pharmaceutical formulations?
What factor influences the rate of chemical change in a drug product?
What factor influences the rate of chemical change in a drug product?
What is the first step in a kinetic study?
What is the first step in a kinetic study?
Why is it important to study the rate of chemical change in a drug product?
Why is it important to study the rate of chemical change in a drug product?
What is the purpose of varying the original conditions in a kinetic study?
What is the purpose of varying the original conditions in a kinetic study?
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?
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?
What type of changes may indicate drug instability in pharmaceutical formulations?
What type of changes may indicate drug instability in pharmaceutical formulations?
What is a common strategy for stabilizing easily oxidizable drugs in pharmaceutical formulations?
What is a common strategy for stabilizing easily oxidizable drugs in pharmaceutical formulations?
What categories of chemical processes can contribute to drug instability?
What categories of chemical processes can contribute to drug instability?
When is drug stability testing particularly critical?
When is drug stability testing particularly critical?
Why is drug stability assurance vital for a marketed drug product?
Why is drug stability assurance vital for a marketed drug product?
