title: Biometrical aspects in the design and analysis of chimpanzees trials assessing hepatitis virus inactivation.
abstract: Hepatitis virus safety of products derived from blood is achieved by screening of individual blood donations and by production processes efficient in eliminating and inactivating residual amounts of hepatitis viruses. A quantitative measure of process inactivation efficiency is the inactivation factor derived from process overchallenging experiments. A product is safe if the corresponding process inactivation factor is as high as the one of a product whose safety has been clinically established. Reliable information on hepatitis safety cannot be obtained by testing commercial end product samples in chimpanzees.
authors.affiliation: Biometry Department of Behringwerke AG, Marburg/Lahn, Fed. Rep. of Germany.
authors.forename: W
authors.initials: W
authors.lastname: Merkle
authors.forename: R
authors.initials: R
authors.lastname: Mauler
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D006518:Hepatitis Viruses / Q000302:isolation & purification*; D006524:Hepatitis, Viral, Animal / Q000382:microbiology / Q000635:transmission*; D002679:Pan troglodytes; D011786:Quality Control; D013242:Sterilization