Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients
Author:
Affiliation:
1. The Haemodynamic Lab; The Section for Heart Failure and Valvular Disease; The Clinic for Heart and Lung Disease; Skåne University Hospital; Lund Sweden
2. Department of Cardiology; Clinical Sciences; Lund University; Lund Sweden
Funder
ALF's foundation
Anna-Lisa and Sven-Erik Lundgren's foundation
Sandoz
Skåne University Hospital's Foundation
Publisher
Wiley
Subject
Transplantation
Reference34 articles.
1. Generic maintenance immunosuppression in solid organ transplant recipients;Ensor;Pharmacotherapy,2011
2. Methods, strengths, weaknesses, and limitations of bioequivalence tests with special regard to immunosuppressive drugs;Gelder;Transpl Int,2013
3. U.S. Food and Drug Administration Statistical approaches to establishing bioequivalence http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf
4. European Medicines Agency Guideline on the investigation of bioequivalence http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
5. Acute cellular rejection the first year after heart transplantation and its impact on survival: a single-centre retrospective study at Skåne University Hospital in Lund 1988-2010;Söderlund;Transpl Int,2014
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3. Report from the 2018 consensus conference on immunomodulating agents in thoracic transplantation: Access, formulations, generics, therapeutic drug monitoring, and special populations;The Journal of Heart and Lung Transplantation;2020-10
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