Abstract
Studies in volunteers are most important in the research and development of a medicinal product or, as defined by the US Food and Drug Administration (FDA), of a drug. The initiation of clinical drug trials in humans requires comprehensive and substantial information about the investigational medical product, particularly toxicology, in order to exclude potential risks for subjects/patients with the greatest probability. Early clinical trials aim to provide first evidence of safety of the investigational medical product. Regulatory and ethical aspects must be taken into account as closely as possible.
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Jäger, S., Schwab, M. (2021). Early Clinical Trials. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-36206-4_43-2
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DOI: https://doi.org/10.1007/978-3-642-36206-4_43-2
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