Abstract
The US Food and Drug Administration is pushing for the pharmaceutical industry to start presenting its animal data in a form standardised for humans. As participants heard at the Management Forum conference, Toxicokinetics - A Practical Approach for Drug Registration, in London, UK, last month, this could mean a return to the ancient art of allometry.
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Mundell, I. FDA may set new requirements for toxicokinetic data. Inpharma Wkly. 890, 5 (1993). https://doi.org/10.2165/00128413-199308900-00005
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DOI: https://doi.org/10.2165/00128413-199308900-00005