ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

@article{Cavero2005ICHSD,
  title={ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.},
  author={Icilio Angelo Girolamo Cavero and William J. Crumb},
  journal={Expert opinion on drug safety},
  year={2005},
  volume={4 3},
  pages={
          509-30
        }
}
The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a… CONTINUE READING
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