18 Questions
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
What type of products have separate protocols for stability studies?
Biotechnological/biological products
How long do pharmaceutical manufacturers retain production samples of drug/drug product after FDA product approval and initial marketing?
5 years or longer
What is an example of a functionality test in stability studies?
Metered-dose delivery system test
What is the responsibility of pharmacy practitioners in regards to stability studies?
Observing signs of product instability and reporting findings
What is the purpose of conducting stability studies under various conditions of storage?
To observe signs of product instability under different storage conditions
What is the purpose of studying the stability of drug products?
To predict the shelf life of a product
What is a sign of drug instability in pharmaceutical formulations?
Change in physical appearance
What factor influences the rate of chemical change in a drug product?
All of the above
What is the first step in a kinetic study?
Measuring the drug's concentration
Why is it important to study the rate of chemical change in a drug product?
To predict the shelf life of a product
What is the purpose of varying the original conditions in a kinetic study?
To determine the influence of changes on drug stability
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
What type of changes may indicate drug instability in pharmaceutical formulations?
Changes in physical appearance, color, odor, or taste
What is a common strategy for stabilizing easily oxidizable drugs in pharmaceutical formulations?
Excluding oxygen, oxidizing agents, and trace metals
What categories of chemical processes can contribute to drug instability?
Oxidation, hydrolysis, and deamination
When is drug stability testing particularly critical?
During preclinical testing and clinical trials
Why is drug stability assurance vital for a marketed drug product?
To ensure patient safety and product effectiveness
This quiz covers the protocols for long-term, intermediate, and accelerated stability studies of chemical drug entities and dosage form products, including testing for physical, chemical, biological, and microbiological attributes.
Make Your Own Quizzes and Flashcards
Convert your notes into interactive study material.
Get started for free
