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Bioanalysis of tucatinib and metabolite, and a five-way cross-validation to support clinical pharmacokinetic analysis: Supplementary data

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posted on 2023-01-18, 09:40 authored by Julie A Meyer, Sharon DeChenne, Charles A Foerder, Shawna M Hengel

Tucatinib, a tyrosine kinase inhibitor of HER2, is approved in multiple regions for metastatic breast

cancer and is being evaluated in metastatic colorectal and gastric cancers. During clinical development,

quantification of tucatinib plasma concentrations for pharmacokinetic analysis was performed using

MS/MS analysis by three laboratories using five different methods. Cross-validation was required to

confirm data across laboratories were comparable. A five-way cross-validation procedure was developed

where bioanalysis performed by one laboratory and method was used as a ‘base’ against which the other

methods were validated. This cross-validation method provides an alternative to multiple head-to-head

comparisons between two methods, and enabled combination of data from multiple tucatinib clinical

trials for a single population pharmacokinetic analysis.

Funding

This study was funded by Seagen Inc. JA Meyer and SM Hengel declare employment and ownership interest in Seagen Inc. SL DeChenne declares employment at Alturas Analytics, Inc., a contract research organization that has received payment for bioanalytical services from Seagen Inc. The sponsor (Seagen Inc.) was involved in the study design and collection, analysis and interpretation of data, as well as data checking of information provided in the manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing and editorial assistance was funded by Seagen Inc. Medical writing support was provided by A Rowe and J Lamprou, and editorial support was provided by T Taylor, all of Prime Global, with funding from Seagen Inc., according to Good Publication Practice 2022 guidelines (https://www.acpjournals.org/doi/10.7326/M22-1460).

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