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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
A new agreement signed between Singapore’s Health Sciences Authority and South Korea’s Ministry of Food and Drug Safety means drug manufacturers in the two regions will be subjected to fewer duplicative good manufacturing practice inspections.