Blog

Working with the Bioanalytical Method Validation Guidance (BMV) in 2019 Bioanalytical Laboratories ADME Stephen Lowes, Ph.D. Working with the Bioanalytical Method Validation Guidance (BMV) in 2019
IntroductionHere at the beginning of 2019 it seems fitting to update my personal thoughts on the status of regulated bioanalysis including how we are adapting to the finalized FDA 2018 BMV Guidance...
2018 Bioanalytical Method Validation Guidance: Key Changes and Considerations Bioanalytical Laboratories Stephen Lowes, Ph.D. 2018 Bioanalytical Method Validation Guidance: Key Changes and Considerations
On Monday 21st May 2018 the US FDA published the final version of the updated Bioanalytical Method Validation (BMV) Guidance for Industry. Considering this is a pivotal guidance for conducting...
Industry Insights from a Veteran Bioanalytical Laboratories ADME Kevin Jones, MBA Industry Insights from a Veteran
My entire professional career, beginning from graduation from college, has been focused on fee-for-service analytical services supporting the pharmaceutical and drug development industry on a global...