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Belgian recommendations for analytical verification and validation of immunohistochemical tests in laboratories of anatomic pathology

authority regarding licensing of medical laboratories) performed in 2016, demonstrated a significant inter laboratory variation in validation procedures of immunohistochemical tests among Belgian ...

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

routine manufacturing of batches, do not contribute to the proper development and qualification of the candidate product. Some considerations regarding suitability of premises for challenge manufacturing ...

Human challenge trial workshop: Focus on quality requirements for challenge agents, Langen, Germany, October 22, 2019.

challenge agents; a focus on strain selection, in particular with regard to strain infectivity, stability and purity; the use of whole genome sequencing; a reference repository of challenge agents, the need ...

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