Episode Summary
DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert at DS InPharmatics and is very technically proficient in all aspects of analytics. In this episode, Ed, Brian, Meranda and Colman expound on the process of analytical method development, including challenges, physiochemical properties that can impact the process and regulatory parameters and agencies that exist.
What We Covered
- 00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation
- 10:27 – Colman’s recommendations for method development and validation plans
- 15:04 – Colman speaks to the commonality of changing methods mid-stream
- 22:01 – Regulatory parameters that exist for analytical method development and validation for drug development
- 35:11 – Other physiochemical properties that can affect method development and the vital role that data plays in the validation process
- 48:32 – Ed, Brian and Meranda thank Colman for joining the show
Tweetable Quotes
Links Mentioned
Analytical Services
Design Space InPharmatics – LinkedIn
Design Space InPharmatics – Twitter
Edward Narke on LinkedIn
Colman Byrne on LinkedIn