Notes
My conversation with a senior FDA pharmacometrician on this issue produced the following response, “From a pharmacometrics point of view one should use good scientific judgment to decide whether to include BLOQ “observations” or not. We are open to all reasonable approaches.” (personal communication)
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Acknowledgments and Disclosures
The author appreciates the technical assistance of Ms. Nancy Pyszczynski. This work was supported by NIH Grant GM 24211.
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Jusko, W.J. Use of Pharmacokinetic Data Below Lower Limit of Quantitation Values. Pharm Res 29, 2628–2631 (2012). https://doi.org/10.1007/s11095-012-0805-6
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DOI: https://doi.org/10.1007/s11095-012-0805-6