Non-Clinical Toxicology and safety assessment of a small molecule

Wat de aanbestedende dienst vraagt

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. Particular attention shall be given to the assessment of renal safety, including the characterization of potential effects of both the test item and the vehicle on renal function and renal toxicity. In addition, the program includes the toxicological assessment of the test item following dermal administration to support the potential clinical evaluation of a semisolid formulation for topical administration. The dermal program is behind a Go/No-Go decision.

Taal van deze aankondiging: Deutsch. Titel en beschrijving tonen we precies zoals de aanbestedende dienst ze heeft gepubliceerd.

How this compares

• This is one of 28 open tenders in Duitsland for Onderzoek en ontwikkeling, en aanverwante adviezen.
• Bidders were given 41 days from publication to the deadline; the median for open tenders in Duitsland is 31 days.

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