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Zoekresultaten - 2 results
Controlled Human Infection Studies: Proposals for guidance on how to design, develop and produce a challenge strain.
reference. In the development phase, CMC documentation is needed for a candidate challenge agent, while standard operating procedure documentation is needed to monitor and control the manufacturing process, ...
Establishment of the Ph. Eur. BRP for varicella vaccine batch 1.
to establish a common reference material for this purpose and establish a Ph. Eur. Biological Reference Preparation. Two candidate reference preparations (X and Y), obtained from 2 different EU ...