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Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.

classified differently by various jurisdictions. Indeed, considerations for challenge agent manufacturing vary between countries due to differences in regulatory oversight, the categorization of the challenge ...

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).

I Skottheim Rusten Source: CPT Pharmacometrics Syst Pharmacol, Volume 6, Issue 7, p.418-429 (2017) Abstract: Inadequate dose selection for confirmatory trials is currently still one of the most challenging ...

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