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Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
Report follows March Webinar run by hVIVO with HIC VAC, Wellcome Trust and IABS
- Applicable local, national and regional guidelines on manufacture and use of challenge agents must be considered.
- As challenge agents are biological products, ICH guidelines should be followed.
- GMP contributes to the right execution of a process duly designed, developed and declared in the CMC documentation.
- Good documentation practice is critical, for adherence to procedures and regulatory requirements and process reconstruction.
- For challenge agents, a case-by-case approach should determine the extent of quality data (CMC and GMP) to be applied.
Full article here: https://www.sciencedirect.com/science/article/pii/S1045105621000737