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Calibration of the Ph. Eur. Biological Reference Preparation (BRP) for Tetanus Vaccine (Adsorbed) Batch 3).
estimate (with 95 % CI) in guinea pigs for all laboratories that provided validresults (n = 6) was 107.9 (64.1-181.7) IU /ampoule. For valid mouse assays (n = 24) the GM potency (with 95 % CI) was147.9 ...
Collaborative Study for the Validation of Alternative in vitro Potency Assays for Human Tetanus Immunoglobulin
vivo assay to be performed to determine the potency of human tetanus immunoglobulins during their development. Furthermore, it states that an in vitro method shall be validated for the batch potency ...