Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulins

Biologicals

Volumn 38, Issue 4, 2010, Pages 501-510

  Gross, S ^a   Janssen, S W J ^b   de Vries, B ^b   Terao, E ^c   Daas, A ^c   Buchheit, K H ^c  

^a PAUL EHRLICH INSTITUT   (Germany)

^b NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^c European Network of National Information Centers   (France)

Author keywords

Animal use replacement; Batch control testing; European Pharmacopoeia; Potency assay; Tetanus immunoglobulin

Indexed keywords

TETANUS ANTIBODY; TETANUS TOXOID;

ACCURACY; ANALYTICAL ERROR; ARTICLE; CONTROLLED STUDY; DRUG POTENCY; ENZYME LINKED IMMUNOSORBENT ASSAY; IN VITRO STUDY; IN VIVO STUDY; INTERMETHOD COMPARISON; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; STANDARDIZATION; VALIDATION STUDY;

ANIMALS; BIOLOGICAL ASSAY; ENZYME-LINKED IMMUNOSORBENT ASSAY; EUROPE; HUMANS; IMMUNOGLOBULINS; INTERNATIONAL COOPERATION; LABORATORY TECHNIQUES AND PROCEDURES; MICE; PHARMACOPOEIAS AS TOPIC; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; TETANUS; TETANUS TOXOID;

ANIMALIA;

EID: 77955272547     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.03.004     Document Type: Article

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