FDA final guidance on toxicokinetics studies reduces numbers of animals needed

In a May 10 Federal Register notice, the U.S. Food and Drug Administration (FDA) announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies.

The Federal Register notice is available at https://www.gpo.gov/fdsys/pkg/FR-2018-05-10/pdf/2018-09930.pdf. All FDA guidance documents are available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm