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The tables can be used for new drug applications, biologics license applications, and supplements to these applications.
FDA released new tables in September 2019 for new drug and biologic applications that provide information about bioanalytical methods for pharmacokinetic assessments, according to a draft guidance issued by FDA.
The guidance is comprised of three tables, as defined by FDA below:
“This guidance provides ready-to-use templates that sponsors can use to submit summaries of bioanalytical methods used in clinical pharmacology studies that involve pharmacokinetic concentration evaluation,” the guidance said. “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.”
The tables can be used for new drug applications, biologics license applications, and supplements to these applications. FDA recommends removing rows and columns from the tables and including them as an Appendix in the “Summary of Biopharmaceutics” section.