From Concept to Medicine - A Comprehensive Drug Development Journey

131 - Validation of Analytical Methods (S9E11)


Listen Later

Delve into the intricacies of the analytical methods validation process, spanning from initial design to rigorous execution. Hear why such methods are so key and are used to not only make sure of good outcomes, but to protect those under your care. Emphasize key validation parameters such as specificity and accuracy, precision, LOD and LOQ, robustness, and system suitability. Break down a number of the processes so that you can become more familiar with their use and implementation.

The analysis highlights the role and importance of following the standards and regulations set forth by ICH and the FDA. Examine case studies, and look at areas and processes to give an example of where validation plays a part in the entire process. Hear of some of the steps taken in testing in the real world, all in an effort to protect the most vulnerable people and ensure their safety every step of the way.

...more
View all episodesView all episodes
Download on the App Store

From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

  • 5
  • 5
  • 5
  • 5
  • 5

5

4 ratings


More shows like From Concept to Medicine - A Comprehensive Drug Development Journey

View all
The Daily by The New York Times

The Daily

110,802 Listeners

The Peter Attia Drive by Peter Attia, MD

The Peter Attia Drive

8,004 Listeners

BioCentury This Week by BioCentury

BioCentury This Week

30 Listeners

The BioCentury Show by BioCentury

The BioCentury Show

11 Listeners