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Dogs died in studies of drug that killed man in French trial

BMJ 2016; 352 doi: http://dx.doi.org/10.1136/bmj.i1228 (Published 29 February 2016) Cite this as: BMJ 2016;352:i1228
  1. Nigel Hawkes
  1. London

Several dogs died in preclinical studies of the experimental drug that killed a human volunteer in a French trial, the French medical safety agency ANSM has confirmed.

But the expert committee the agency established to review the trial’s conduct concluded that these deaths were to be expected in animal testing designed to establish a safe dose for human administration. The protocol for the first in human trial recorded that this “no observed adverse effect level” was determined for mice, rats, dogs, and monkeys.

As part of these studies, ANSM said, “very high doses are administered to determine the maximum tolerated doses, which can …

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