Human clinical trials are expensive, but a compulsory precondition for marketing authorisations. Approximately 40% of a drug’s development costs are incurred in the course of these trials. Depending on the substance and the indication many hundreds or thousands of patients have to be treated with the investigational new drug in order to gain sufficient data on its safety and efficacy. SANOCHEMIA generally finances clinical trials up to and including Phase II (during which the dose and safety of the investigational new drug is established in patients). The more cost-intensive phase III clinical trials are conducted in co-operation with marketing partners. This strategy has the advantage to share costs and risks with a partner. It allows incomes to be generated during the phase III drug development phase and after marketing through the receipt of milestone payments. |
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