Clinical Pharmacology Podcast with Nathan Teuscher

Handling BLQ samples (Ep. 13)

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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


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    Clinical Pharmacology Podcast with Nathan TeuscherBy Nathan Teuscher
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