Podcast
Questions and Answers
What attributes of the drug product should stability studies include testing for?
What attributes of the drug product should stability studies include testing for?
Physical, chemical, biological, and microbiological attributes
Why is it important to test attributes susceptible to change during storage in stability studies?
Why is it important to test attributes susceptible to change during storage in stability studies?
To influence quality, safety, and/or efficacy
What should stability studies aim to cover in relation to the drug product's attributes?
What should stability studies aim to cover in relation to the drug product's attributes?
Attributes susceptible to change during storage
