Studies Pertinent to Pharmacokinetics Using Human Biomaterials

The guideline defines human biomaterials as proteins, cells, tissues, and related materials derived from human sources, which are used in vitro or ex vivo to assess PK properties of drug substances. The types of studies identified are plasma protein binding studies, and hepatic metabolism and drug interaction studies. Examples include cultured human colonic cells that are used to assess permeability through biological membranes and transport processes, and human albumin that is used to assess plasma protein binding. Of particular importance is the use of human biomaterials such as hepatocytes and/or hepatic microsomes to study metabolic pathways and to assess drug-drug interactions with these pathways.

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