Regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan.
Koga
J
J
Japanese Pharmaceutical Manufacturers Association, Kobe, Japan.
D001688:Biological Products / Q000592:standards; D002478:Cells, Cultured / Q000821:virology; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D005060:Europe; D006801:Humans; D007564:Japan; D014481:United States; D014780:Viruses / Q000302:isolation & purification*
D001688:Biological Products