Duration: 60 Minutes
This course will cover an introduction to the chemistry of light. Its role and understanding for pharmaceutical applications. We will look at the ICH Q1B Photostabilty guideline and overview its minimum exposure requirements. We will interpret the terms presented in the guideline for background understanding. We will cover the types of light sources, means of sample presentation, execution of sample analysis and types of tests, and practical means of interpretation of the results for a photostability decision. Present a format for a photostability protocol. Learn of ways to protect photoliable drugs. A wrap up with a summary of key take home concepts.
Why You Should Attend:
In conducting drug development in a global environment, it is important to be able to interpret and execute the requirements of regulatory standards. The International Conference on Harmonization (ICH) has published a Quality guideline on photostability (Q1B) that must be understood and executed correctly for subsequent regulatory approval. This course presents background knowledge and practical interpretation of the guideline to come to a photostability decision for your drug development program.
Areas Covered In The Session:
Who Should Attend: