Toxicology White Paper

For nonclinical studies, ISR should be conducted at least once in each species, preferably in the first toxicology study. This could be a validation activity. Guidance was to follow the recommendations from the 2007 white paper [10]. Evaluation of ISR in clinical studies was recommended for all bioequivalence/ comparability studies and, where applicable, for the first-in-human study and diseased patient population studies. 

A recent White Paper from the European Commission has unveiled the shape of things to come in the area of toxicological testing and authorization of chemicals. The Paper proposes that industry perform toxicological and ecotoxicological testing of all existing commercial substances and prepare risk assessments to demonstrate either that they are safe or should be authorized for future use only in restricted ways. 

The White Paper is now being submitted to the European Parliament. If signed into law, this strategy will ensure the largest volume of toxicological and ecotoxicological testing that has yet been seen. 

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