The 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 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 templates can be used for new drug applications (NDAs), biologics license applications (BLAs), and supplements to these applications.
General recommendations regarding bioanalytical method validation can be found in the May 2018 guidance entitled Bioanalytical Method Validation3 and the June 2018 draft guidance entitled M10 Bioanalytical Method Validation.
Download the Guidance Document: