WitrynaThe Investigational Medicinal Product Dossier is a document divided in four distinct sections. It provides information on (i) the quality, manufacture and control of the IMP, (ii) the non-clinical studies conducted with the IMP, (iii) the clinical use of the IMP, and (iv) the overall risk / benefit assessment of the IMP in the proposed trial. WitrynaThe IMPD is divided into four sections which summarizes the relevant information on quality, pre-clinical, clinical studies, including critical analyses of the non-clinical and clinical data related to the possible risks and benefits of the proposed study, as well as any available previously generated human data and an assessment of the overall …
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