Regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan.
Dinowitz
M
M
Genentech, Inc., South San Francisco CA, USA.
Sernatinger
J
J
Wiebe
M
M
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*