7.7 Animal studies: (i) Where studies in an animal model have been undertaken to provide evidence of conformity with the Essential Principles related to functional safety and performance, detailed information should be contained in the dossier. (ii) The dossier should describe the study objectives, methodology, results, analysis and conclusions and document conformity with Good Laboratory Practices. The rationale (and limitations) of selecting the particular animal model should be discussed. 7.8 Stability data: If available, real-time aging data shall be submitted to support the claimed shelf life. However, if real-time data is not available, accelerated stability data shall be submitted to support the claimed shelf life. Such a provisional claimed shelf life may be approved provided that the manufacturer immediately initiates real-time stability testing to validate the proposed shelf life. After completion of the real time stability analysis, real-time stability data shall be submitted in support of the claimed shelf life.
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