Description

In today’s episode I discuss BLQ handing for both non-compartmental and modeling analysis approaches. I discuss how BLQ samples are defined, methods for analyzing them, and situations when you should use different analysis approaches.

Links discussed in the show:

• FDA guidance on bioanalytical method validation
• ICH M10 guidance on bioanalytical method validation
• Handling data below the limit of quantitation in mixed effects models
• Ways to fit a PK model with some data below the quantification limit
• You can connect with me on LinkedIn and send me a message
• Send me a message
• Sign up for my newsletter

Copyright Teuscher Solutions LLC

All Rights Reserved