Are there specific guidelines for stability testing of inhalation products?
How can I ensure the reliability of stability testing results?
Can stability data be used to support a change in manufacturing process?
What are the implications of stability data failing to meet regulatory requirements?
How do I demonstrate that a drug product remains stable after reconstitution?
What is the impact of regulatory changes on stability study requirements?
Can I adjust storage conditions during a stability study without compromising data?
How do I establish the appropriate storage conditions for biologics?
What is the role of packaging integrity in stability studies?
Can stability data obtained from accelerated studies be used to extend shelf life?