Handling BLQ samples (Ep. 13)

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