Open-label trials and drug registration: a European regulator's view.
Casteels
M
M
Farmacologie, Katholieke Universiteit Leuven, Leuven, Belgium. minne.casteels@med.kuleuven.be
Flamion
B
B
D015982:Bias; D004311:Double-Blind Method; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D023381:Endpoint Determination; D005062:European Union; D005343:Fibrinolytic Agents / Q000592:standards / Q000627:therapeutic use*; D006801:Humans; D019934:International Normalized Ratio; D018579:Patient Selection; D011364:Professional Practice; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D016037:Single-Blind Method; D019851:Thrombophilia / Q000188:drug therapy; D014812:Vitamin K / Q000037:antagonists & inhibitors
D005343:Fibrinolytic Agents; D014812:Vitamin K