Non-Clinical Toxicology and safety assessment of a small molecule

Achoimre oifigiúil · Deutsch

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The overall objective of the present project is to conduct a comprehensive nonclinical toxicology and safety assessment program for a small-molecule drug candidate. The program is intended to characterize the toxicological and safety pharmacology profile of the test item following intravenous infusion and to generate the nonclinical safety data required to support a first-in-human clinical trial and subsequent clinical development. The program shall be conducted in accordance with applicable regulatory requirements and guidelines and shall generate data and documentation suitable for regulatory submissions in the European Union and the United States.…

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