Guidance for industry [[electronic resource] ] : assay development for immunogenicity testing of therapeutic proteins
Pubbl/distr/stampa
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : , : Center for Biologics Evaluation and Research, , [2009]
Descrizione fisica
1 online resource (20 pages) : illustrations
Soggetti
Immunogenetics - United States
Biological assay
Proteins - Therapeutic use - Testing
Lingua di pubblicazione
Inglese
Formato
Materiale a stampa
Livello bibliografico
Monografia
Note generali
"Draft guidance."
"CMC."
"December 2009."
Nota di bibliografia
Includes bibliographical references (pages 19-20).