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
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