ICH Finalizes Guide To Cutting Down On Rat Carcinogenicity Studies
An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.
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The International Conference on Harmonisation has approved plans for developing a new guideline on rodent carcinogenicity testing of human drugs1. The document, when finalised and adopted, could result in fewer drugs requiring two-year rodent carcinogenicity studies in cases where other data is available to support patient safety.
Following feedback from its clinical trials expert group, the European Commission has published new and updated templates that sponsors can use to prepare study applications that would be acceptable in all the EU member states.
A compilation of the differences and similarities in regulatory requirements for decentralized trials across the EU member states could help sponsors better understand the nuances per country.