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Exponential Developments

“The expected exposure in humans at a dose to be given, in comparison to the exposure at which certain effects were observed in animals or earlier in the study in humans, is considered more relevant than the relative dose levels between animals and humans,” claims the first-in-human (FIH) guidance.

In July 2017, the EMA revised its guidance on FIH clinical trials, providing strategies to identify and mitigate risks for trial participants. This article explores how modern clinical study strategies can be utilised in early phase studies to not only satisfy the new regulatory risk mitigation guidance principles, but also incorporate efficiencies in study design and certainty of decision-making. The purpose of this article is not to restate information that has been provided in earlier FIH guidance documents, but to highlight the new recommendations being suggested.

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Bradley Joblin has a doctorate from the University of Zurich, Switzerland. Having held senior management and director positions in clinical research at the headquarters of global pharmaceutical companies and smaller biotechnology companies, his experience is in clinical study implementation, early and late phase clinical study design, and clinical development strategy. Brad founded his own company providing clinical study and development advice to the clinical research community including biotech companies and medical research institutes. He joined Q-Pharm at the start of 2017 to offer scientific oversight and management within Q-Pharm, as well as study design and development strategies to clients.
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