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Ethical approval for controlled human infectious model clinical trial protocols- A workshop report.
Shobana; Neels, Pieter Source: Biologicals, Volume 85 (2024) Keywords: Drug Development Healthy Volunteers Humans Research Design Abstract: Controlled Human Infectious Model studies (CHIM) involve ...
Regulatory workshop on challenge strain development and GMP manufacture- A stakeholder meeting report.
Hassan, Khaole; Hoefnagel, Marcel; Kamerling, Ingrid; Krut, Oleg; Lane, Chelsea; Liebers, Reinhard; Luke, Catherine; Wim Van Molle; Morel, Sandra; Neels, Pieter; Roestenberg, Meta; Rubbrecht, Michelle; ...
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
Jeffrey M Bethony; Linda Schellhaas; Nazziwa, Winfred Badanga; Eric Karikari-Boateng; Prachumsri, Jetsumon Sattabongkot; Paula Salmikangas; Dean Smith; Peter Stjärnkvist; Wim Van Molle; Marc Baay; Neels ...