Abstract
A main milestone in drug development is the initiation of studies in humans. Studies with a new medicinal product require approval by regulatory authorities and ECs (Institutional Review Board: IRB). To take this step, the key information required includes the following:
The works must be conceived with fire in the soul but executed with clinical coolness.
Joan Miro
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© 2015 Springer-Verlag Berlin Heidelberg
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Joubert, P.H., Rogers, S.M. (2015). Initiating Clinical Programs (IND and IMPD). In: Strategic Scientific and Medical Writing. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-48316-9_11
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DOI: https://doi.org/10.1007/978-3-662-48316-9_11
Publisher Name: Springer, Berlin, Heidelberg
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