title: Hepatitis B viral clearance studies using duck virus model.
abstract: We have shown data to suggest that the in vivo duck hepatitis B virus system represents an excellent animal model system for the study of hepatitis B virus. Because of the similarity of DHBV to human HBV (including comparable results in virus inactivation studies), the high level of sensitivity of the DHBV assay, and the rapidity, ease, and relative low cost of obtaining results, we propose that the in vivo DHBV titration system be used as a model for human HBV in process validation studies. Data generated in such validation studies have, in fact, been submitted by a number of blood products manufacturers to the U.S. F.D.A. in support of IND applications.
authors.affiliation: Quality Biotech Inc., Camden, NJ 08104.
authors.forename: Z
authors.initials: Z
authors.lastname: Long
authors.forename: C S
authors.initials: CS
authors.lastname: Sun
authors.forename: E M
authors.initials: EM
authors.lastname: White
authors.forename: B
authors.initials: B
authors.lastname: Horowitz
authors.forename: A F
authors.initials: AF
authors.lastname: Sito
mesh_terms: D000818:Animals; D001681:Biological Assay; D004195:Disease Models, Animal; D004372:Ducks / Q000382:microbiology*; D018347:Hepadnaviridae Infections / Q000382:microbiology; D015611:Hepatitis B Virus, Duck / Q000302:isolation & purification* / Q000502:physiology; D006515:Hepatitis B virus; D006358:Hot Temperature; D006801:Humans; D002679:Pan troglodytes / Q000382:microbiology; D012449:Safety; D012680:Sensitivity and Specificity; D013045:Species Specificity; D014766:Viremia / Q000382:microbiology*; D014773:Virology / Q000379:methods*