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Regulatory Focus™ > News Articles > 2019 > 10 > FDA Unveils New Tables for Submitting Bioanalytical Methods

FDA Unveils New Tables for Submitting Bioanalytical Methods

Posted 04 October 2019 | By Zachary Brennan 

FDA Unveils New Tables for Submitting Bioanalytical Methods

The US Food and Drug Administration (FDA) recently released tables that can be included in submissions for new drug and biologic applications to provide information regarding the bioanalytical methods for pharmacokinetic assessments.

“The templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs) that quantitatively determine the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin,” FDA explains

The guidance includes three tables:
  • “Table 1. Bioanalytical Method Life Cycle Information: We recommend that you prepare Table 1 in landscape format for your submission.
  • Table 2a. Summary Method Performance: Table 2a can be used to provide information for each bioanalytical method used to evaluate pharmacokinetic concentrations, using one method per analyte per table.
  • Table 2b. Summary of Method Modifications and Cross-Validation Results: If the method described in Table 2a was modified, describe the modifications and crossvalidation results can be described in Table 2b.”
FDA recommends that the tables be included as an Appendix in the Summary of Biopharmaceutics located in eCTD 2.7.1.

“In addition to including these tables in the Appendix, we request you also submit both tables, when they are provided, in docx format in eCTD 2.7.1. Finally, you can include any additional bioanalytical information that might be relevant for the review of your submission,” FDA says.

Back in June, FDA also released draft guidance from the International Council for Harmonisation, known as M10, on bioanalytical method validation.

Bioanalytical Methods Templates


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