Regulatory watch: Non-inferiority-trial discussions impact new drug applications.
D000617:Aminoglycosides / Q000493:pharmacokinetics; D000890:Anti-Infective Agents / Q000493:pharmacokinetics*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation / Q000331:legislation & jurisprudence*; D006020:Glycopeptides / Q000493:pharmacokinetics; D006801:Humans; D000077427:Lipoglycopeptides; D011743:Pyrimidines / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D014640:Vancomycin / Q000031:analogs & derivatives
D000617:Aminoglycosides; D000890:Anti-Infective Agents; D006020:Glycopeptides; D000077427:Lipoglycopeptides; D011743:Pyrimidines; C486448:iclaprim; C100708:oritavancin; D014640:Vancomycin; C487637:telavancin