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.
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.