Regulatory expectation for data on viral testing and process evaluation for phase I studies and product licensing in the United States, Europe and Japan.
Ridgway
A
A
Biotechnology Section, Bureau of Biologics, Ottawa, Ont., Canada.
D002170:Canada; D017321:Clinical Trials, Phase I as Topic / Q000191:economics / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004340:Drug Contamination / Q000331:legislation & jurisprudence; D006801:Humans; D017387:Investigational New Drug Application / Q000191:economics / Q000331:legislation & jurisprudence; D014481:United States; D014780:Viruses / Q000302:isolation & purification*