Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products
Committee for Proprietary Medicinal Products. CPMP/BPWG/198/95 rev.1. London, 19 October
Committee for Proprietary Medicinal Products. Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products. CPMP/BPWG/198/95 rev.1. London, 19 October 2000.
(2000)
2
0031718547
The history and conduct of safety assessment of marketed medicines studies in the UK
Palmer L. The history and conduct of safety assessment of marketed medicines studies in the UK. Int J Pharm Med 1998; 12: 181-183.
Guidelines for company sponsored safety assessment of marketed medicines
Medicines Control Agency, Committee on Safety of Medicines, Royal College of General Practitioners, British Medical Association and Association of the British Pharmaceutical Industry
Medicines Control Agency, Committee on Safety of Medicines, Royal College of General Practitioners, British Medical Association and Association of the British Pharmaceutical Industry. Guidelines for company sponsored safety assessment of marketed medicines. Br J Clin Pharmacol 1994; 38: 93-97.
A cross-over pharmacokinetic and thrombogenicity study of a prothrombin complex concentrate and a purified factor IX concentrate
Thomas DP, Hampton KK, Dasani H, et al. A cross-over pharmacokinetic and thrombogenicity study of a prothrombin complex concentrate and a purified factor IX concentrate. Br J Haematol 1994; 87: 782-788.
Clinical experience with a highly purified factor IX concentrate in patients undergoing surgical operations
Thomas DP, Lee CA, Colvin BT, et al. Clinical experience with a highly purified factor IX concentrate in patients undergoing surgical operations. Haemophilia 1995; 1: 17-23.
A new approach to pharmacovigilance in haemophilia: Experience with Replenate®, a high-purity factor VIII concentrate
in press
Gascoigne EW, Dash CH, Harman C, Wilmot D. A new approach to pharmacovigilance in haemophilia: experience with Replenate®, a high-purity factor VIII concentrate. Pharmacoepidemiology and Drug Safety; in press.
UK Haemophilia Centre Directors Organisation. UKHCDO: Oxford, UK
UK Haemophilia Centre Directors Organisation. Report on the Annual Returns for 1996. UKHCDO: Oxford, UK, 1998.
(1998)
13
0026548917
Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs
Ehrenforth S, Kreuz W, Scharrer I, et al. Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs. Lancet 1992; 339: 594-598.
Clinical safety data management - Definitions and standards for expedited reporting
ICH Harmonised Tripartite Guideline
ICH Harmonised Tripartite Guideline. Clinical safety data management - definitions and standards for expedited reporting. Fed Regist 1995; 60: 11284-11287.