TK for an IV Administered Drug

Dear Colleagues,


A CRO just finished a teratology study with TK in which the drug was administered intravenously. The TK report addressed back-extrapolated Co instead of Cmax. In the previously conducted general tox studies in rats and dogs at a different CRO, their kineticist used Cmax, which of course, was always achieved at the first time-point (5 minutes). I am curious as to opinions/experience on using back-extrapolated Co vs. Cmax in the TK assessment for IV tox studies. Thanks.




Barry S. Levine, DSc

Diplomate, American Board of Toxicology

Levine Tox Consulting, LLC

Consultants in Toxicology

  and Nonclinical Development

2440 N. Lakeview Ave.

Suite 7EF

Chicago, IL 60614

Tel (773) 697-4846

Fax (312) 546-6334

Cell (312) 550-0100




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