Assessing Efficacy and Therapeutic Claims in Emerging Indications for Recombinant Factor VIIa: Regulatory Perspectives

This publication has 31 references indexed in Scilit:

• Evidence-based practice of transfusion medicine: is it possible and what do the words mean?
  Transfusion Medicine Reviews, 2004
• Modelling the economic impact of recombinant activated Factor VII compared to activated prothrombin-complex concentrate in the home treatment of a mild to moderate bleed in adults with inhibitors to clotting Factors VIII and IX in the UK
  Journal of Medical Economics, 2002
• Using high quality clinical databases to complement the results of randomised controlled trials: the case of recombinant human activated protein C
  BMJ, 2001
• Interim analyses and sequential designs in phase III studies
  British Journal of Clinical Pharmacology, 2001
• Users' Guides to the Medical Literature
  JAMA, 2000
• Efficacy and Safety of Recombinant Factor VIIa in the Prophylaxis of Bleeding in Various Surgical Procedures in Hemophilic Patients with Factor VIII and Factor IX Inhibitors
  Seminars in Thrombosis and Hemostasis, 2000
• Methods in health services research: Interpreting the evidence: choosing between randomised and non-randomised studies
  BMJ, 1999
• Improved Survival with an Implanted Defibrillator in Patients with Coronary Disease at High Risk for Ventricular Arrhythmia
  New England Journal of Medicine, 1996
• Corticosteroids Prevent Early Deterioration in Patients with Moderately Severe Pneumocystis carinii Pneumonia and the Acquired Immunodeficiency Syndrome (AIDS)
  Annals of Internal Medicine, 1990
• Randomized versus historical controls for clinical trials
  The American Journal of Medicine, 1982