Regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan.
Moriguchi
H
H
Research and Development Division, Ministry of Health and Welfare, Tokyo, Japan.
D001688:Biological Products / Q000592:standards; D017321:Clinical Trials, Phase I as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004340:Drug Contamination / Q000331:legislation & jurisprudence; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007564:Japan; D014481:United States; D014780:Viruses / Q000302:isolation & purification*
D001688:Biological Products