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In order to perform a toxicological evaluation and risk assessment of the organic impurity under review, its chemical structure should be provided. Furthermore, information on the product administration route, the maximum daily intake and the treatment duration should also be provided by the client.
Please note that this information is necessary for performing an accurate and reliable toxicological evaluation and risk assessment. The purpose of this questionnaire is to compile and interpret the results on both the impurity and the drug product. In this way, the conclusions extracted in the subsequent risk analysis will be reliable for regulatory purposes.
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