[1]
|
Association of the British Pharmaceutical Industry (1996) Guidelines for company sponsored safety assessment of marketed medicines (SAMM). In: ABPI Compendium of Data Sheets and Summaries of Product Characteristics. Datapharm Publications, London.
|
[2]
|
Rawlins, M.D. and Jefferys, D.B. (1991) Study of United Kingdom product license applications containing new active substances, 1987-1989. British Medical Journal, 302, 223-225. doi:10.1136/bmj.302.6770.223
|
[3]
|
Dockhorn, R., Vanden Burgt, J.A., Ekholm, B.P., Donnell, D. and Cullen, M.T. (1995) Clinical equivalence of a novel non-chlorofluorocarbon-containing salbutamol sulfate metered-dose inhaler and a conventional chlorofluorocarbon inhaler in patients with asthma. Journal of Allergy and Clinical Immunology, 96, 50-56.
doi:10.1016/S0091-6749(95)70032-3
|
[4]
|
Kleerup, E.C., Tashkin, D.P., Cline, A.C. and Ekholm, B.P. (1996) Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered dose inhaler in patients with asthma. Chest, 109, 702-707.
doi:10.1378/chest.109.3.702
|
[5]
|
Tinkelman, D.G., Bleecker, E.R., Ramsdell, J., Ekholm, B.P., Klinger, N.M., Colice, G.L. and Slade, H.B. (1998) Proventil HFA and Ventolin have similar safety profiles during regular use. Chest, 113, 290-296.
doi:10.1378/chest.113.2.290
|
[6]
|
Bleecker, E.R., Tinkelman, D.G., Ramsdell, J., Ekholm, B.P., Klinger, N.M., Colice, G.L. and Slade, H.B. (1998) Proventil HFA provides bronchodilation comparable to Ventolin over 12 weeks of regular use in asthmatics. Chest, 113, 283-289. doi:10.1378/chest.113.2.283
|
[7]
|
Craig-McFeely, P.M., Wilton, L.V., Soriano, J.B., Maier, W.C. and Shakir, S.A. (2003) Prospective observational cohort safety study to monitor the introduction of a non-CFC formulation of salbutamol with HFA134a in England. International Journal of Clinical Pharmacology, Therapy, & Toxicology, 41, 67-76.
|
[8]
|
Report of the Auditor General of Canada to the House of Commons (2011) Regulating pharmaceutical drugs— Health Canada. Minister of Public Works and Government Services, 26.
|
[9]
|
Ayres, J.G., Frost, C.D., Holmes, W.F., Williams, D.R.R. and Ward, S.M. (1998) Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines. British Medical Journal, 317, 926-930.
doi:10.1136/bmj.317.7163.926
|
[10]
|
http://www.stattools.net/SSize2props_Pgm.php
|
[11]
|
European Agency for the Evaluation of Medicinal Products (1995) Guideline for postmarketing surveillance studies for metered dose inhalers with new propellants. EAEMP, London.
|
[12]
|
Hendeles, L., Colice, G.L. and Meyer, R.J. (2007) Withdrawal of albuterol inhalers containing chlorofluorocarbon propellants. New England Journal of Medicine, 356, 1344-1351. doi:10.1056/NEJMra050380
|