title: Regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan.
authors.affiliation: Genentech, Inc., South San Francisco CA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Dinowitz
authors.forename: J
authors.initials: J
authors.lastname: Sernatinger
authors.forename: M
authors.initials: M
authors.lastname: Wiebe
mesh_terms: D000818:Animals; D016466:CHO Cells; D002478:Cells, Cultured / Q000821:virology; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence* / Q000379:methods; D006224:Cricetinae; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D007564:Japan; D014481:United States; D014780:Viruses / Q000302:isolation & purification*