« Previous
Next »
The Journal of Heart and Lung Transplantation
Volume 28, Issue 7
, Pages 655-660
, July 2009
Generic Drug Immunosuppression in Thoracic Transplantation: An ISHLT Educational Advisory
References
- . The dose makes the medicine. Drug Discovery Today. 2006;11:550–555
- . Guidance for industry (Bioequivalence requirements: critical dose drugs (2006)). http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/bio/critical_dose_critique-eng.php
- . Generic substitution: the use of medicinal products containing different salts and implications for safety. Eur J Pharm Sci. 2006;28:1–6
- . Part C Drugs, Division I General, C.01.001 ((1) Definition of serious adverse reaction). http://laws.justice.gc.ca/en/showdoc/cr/C.R.C.-c.870/bo-ga:l_C-gb:s_C_01_001//en#anchorbo-ga:l_C-gb:s_C_01_001
- . United States Food and Drug Administration requirements for approval of generic drug products. J Clin Psychiatry. 2001;62(suppl 5):4–9
- Birkett DJ. Generics—equal or not? Austral Prescriber 3003;26:85–7.
- Federal Regulations 21 CFR 320. Washington, DC: DHHS; 1998;
- Bioequivalence and interchangeability of narrow therapeutic range drugs. J Pharm Pharmaceut Sci. 1998;1:2–7
- Guidelines for bioequivalence studies for generic products [in Japanese]; 2006. www.nihs.go.jp/drug/be-guide/GL061124_BE.pdf
- Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Washington, DC: FDA; 2000;http://www.fda.gov/cder/guidance/3618fnl.pdf
- . Review of select transplant subpopulations at high risk of failure from standard immunosuppressive therapy. Clin Transplant. 2000;14:439–448
- . Variations in bioavailability of cyclosporine and relationship to clinical outcome in renal transplant subpopulations. Transplant Proc. 1995;27:837–839
- Cyclosporine pharmacokinetics and dose monitoring after lung transplantation: comparison between cystic fibrosis and other conditions. Transplantation. 2003;76:683–688
- . Sublingual tacrolimus for immunosuppression in lung transplantation: a potentially important therapeutic option in cystic fibrosis. J Respir Med. 2002;1:91–98
- Quantifying the ‘hidden’ lactose in drugs used for the treatment of gastro-intestinal conditions. Aliment Pharmacol Ther. 2009;29:677–687
- Disparate distribution of 16 candidate single nucleotide polymorphisms among racial and ethnic groups of pediatric heart transplant patients. Transplantation. 2006;82:1774–1780
- Genetic polymorphisms impact the risk of acute rejection in pediatric heart transplantation: a multi-institutional study. Transplantation. 2008;85:1632–1639
- Association study of ABCB1 and CYP3A5 gene polymorphisms with sirolimus trough concentration and dose requirements in Chinese renal transplant recipients. Biopharm Drug Dispos. 2008;29:1–5
- Tacrolimus pharmacogenetics: the CYP3A5*1 allele predicts low dose-normalized tacrolimus blood concentrations in whites and South Asians. Transplantation. 2005;79:499–502
- . Federal Register. 2000;65:75717
- . Development of Sang-35: a cyclosporine formulation bioequivalent to Neoral. Clin Transplant. 1998;12:518–524
- Administration diluents differentiate Neoral from a generic cyclosporine oral solution. Clin Transplant. 2002;16:306–309
- Differentiation of innovator versus generic via a drug interaction on sirolimus. Eur J Clin Pharmacol. 2006;62:361–366
- Developmental pharmacology—drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157–1167
- . A physician survey on generic drugs and substitution of critical dose medications. Arch Intern Med. 1997;157:2080–2088
Presented in part at the 29th annual scientific meeting of the ISHLT, April 2009, Paris, France. This study was commissioned by the Board of Directors of the ISHLT and approved at all stages by the Education Committee of the ISHLT.
PII: S1053-2498(09)00318-0
doi: 10.1016/j.healun.2009.05.001
© 2009 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
« Previous
Next »
The Journal of Heart and Lung Transplantation
Volume 28, Issue 7
, Pages 655-660
, July 2009
