-
1
-
-
84899911769
-
-
EMA. Guideline on clinical investigation of immunosuppressants for solid organ transplantation. Available from: (accessed 24 July 2008).
-
EMA. Guideline on clinical investigation of immunosuppressants for solid organ transplantation. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003593.pdf (accessed 24 July 2008).
-
-
-
-
2
-
-
84899952865
-
-
NICE. Renal transplantation - immunosuppressive regimens (adults). TA 85. London, NICE. Available from: (accessed 1 June 2013).
-
NICE. Renal transplantation - immunosuppressive regimens (adults). TA 85. London, NICE 2004. Available from: http://guidance.nice.org.uk/TA85/Guidance/pdf/English (accessed 1 June 2013).
-
(2004)
-
-
-
3
-
-
10844292763
-
Immunosuppressive drugs for kidney transplantation
-
Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med 2004: 351: 2715.
-
(2004)
N Engl J Med
, vol.351
, pp. 2715
-
-
Halloran, P.F.1
-
4
-
-
84899934522
-
-
Summary of Product Characteristics. Adoport 0.5 mg, 1 mg, 5 mg hard capsules. Available from: (accessed 1 July 2013).
-
Summary of Product Characteristics. Adoport 0.5 mg, 1 mg, 5 mg hard capsules. Available from: www.emc.medicines.org.uk (accessed 1 July 2013).
-
-
-
-
5
-
-
84899899375
-
-
Summary of Product Characteristics. Intas 0.5 mg, 1 mg hard capsules. Available from: (accessed 13 December 2013).
-
Summary of Product Characteristics. Intas 0.5 mg, 1 mg hard capsules. Available from: http://www.sukl.cz (accessed 13 December 2013).
-
-
-
-
6
-
-
84899938987
-
-
Public Assessment Reports For Various Generic Tacrolimus Formulations (PharOS). Available from: (accessed 13 December 2013).
-
Public Assessment Reports For Various Generic Tacrolimus Formulations (PharOS). Available from: http://www.mhra.gov.uk (accessed 13 December 2013).
-
-
-
-
7
-
-
84899968259
-
-
Tacrolimus Capsule [Accord Healthcare, Inc.]. Available from: (accessed 13 December 2013).
-
Tacrolimus Capsule [Accord Healthcare, Inc.]. Available from: http://dailymed.nlm.nih.gov (accessed 13 December 2013).
-
-
-
-
8
-
-
84899940563
-
-
EMA. Guideline on the investigation of bioequivalence. 20 January 2010. Available from: (accessed 31 October 2012).
-
EMA. Guideline on the investigation of bioequivalence. 20 January 2010. Available from: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf (accessed 31 October 2012).
-
-
-
-
9
-
-
82755192464
-
European Society for Organ Transplantation advisory committee recommendations on generic substitution of immunosuppressive drugs
-
van Gelder T. European Society for Organ Transplantation advisory committee recommendations on generic substitution of immunosuppressive drugs. Transpl Int 2011: 24: 1135.
-
(2011)
Transpl Int
, vol.24
, pp. 1135
-
-
van Gelder, T.1
-
10
-
-
84899959105
-
-
Public Assessment Report of the Medicines Evaluation Board in the Netherlands; Tacrolimus Sandoz 0.5 mg, 1.0 mg and 5 mg capsules. NL/H/1340/001-003/DC/1 Feb 2010. Available from: (accessed 27 May 2013).
-
Public Assessment Report of the Medicines Evaluation Board in the Netherlands; Tacrolimus Sandoz 0.5 mg, 1.0 mg and 5 mg capsules. NL/H/1340/001-003/DC/1 Feb 2010. Available from: http://db.cbg-meb.nl/mri/par/nlh-1342-001-002-003.pdf (accessed 27 May 2013).
-
-
-
-
11
-
-
80052977493
-
Bioequivalence of two tacrolimus formulations under fasting conditions in healthy male subjects
-
Mathew P, Mandal J, Patel K et al. Bioequivalence of two tacrolimus formulations under fasting conditions in healthy male subjects. Clin Ther 2011: 33: 1105.
-
(2011)
Clin Ther
, vol.33
, pp. 1105
-
-
Mathew, P.1
Mandal, J.2
Patel, K.3
-
12
-
-
84879461018
-
Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison
-
Herranz M, Morales-Alcelay S, Corredera-Hernández MT et al. Bioequivalence between generic tacrolimus products marketed in Spain by adjusted indirect comparison. Eur J Clin Pharmacol 2013: 69: 1157.
-
(2013)
Eur J Clin Pharmacol
, vol.69
, pp. 1157
-
-
Herranz, M.1
Morales-Alcelay, S.2
Corredera-Hernández, M.T.3
-
13
-
-
84899903643
-
-
Summary of Product Characteristics: Prograf 0.5 mg, 1 mg, 5 mg hard capsules. Available from: (accessed 1 June 2013).
-
Summary of Product Characteristics: Prograf 0.5 mg, 1 mg, 5 mg hard capsules. Available from: www.emc.medicines.org.uk (accessed 1 June 2013).
-
-
-
-
14
-
-
80052269422
-
Immunosuppression, generic drugs and the FDA
-
Klintmalm GB. Immunosuppression, generic drugs and the FDA. Am J Transplant 2011: 11: 1765.
-
(2011)
Am J Transplant
, vol.11
, pp. 1765
-
-
Klintmalm, G.B.1
-
15
-
-
80054930281
-
Generic maintenance immunosuppression in solid organ transplant recipients
-
Ensor CR, Trofe-Clark J, Gabardi S, McDevitt-Potter LM, Shullo MA. Generic maintenance immunosuppression in solid organ transplant recipients. Pharmacotherapy 2011: 31: 1111.
-
(2011)
Pharmacotherapy
, vol.31
, pp. 1111
-
-
Ensor, C.R.1
Trofe-Clark, J.2
Gabardi, S.3
McDevitt-Potter, L.M.4
Shullo, M.A.5
-
16
-
-
0043072348
-
Report of the american society of transplantation conference on immunosuppressive drugs and the use of generic immunosuppressants
-
Alloway RA, Isaacs R, Lake K et al. Report of the american society of transplantation conference on immunosuppressive drugs and the use of generic immunosuppressants. Am J Transplant 2003: 3: 1211.
-
(2003)
Am J Transplant
, vol.3
, pp. 1211
-
-
Alloway, R.A.1
Isaacs, R.2
Lake, K.3
-
17
-
-
84859266161
-
Generic immunosuppression in solid organ transplantation: a Canadian perspective
-
Harrison JJ, Schiff JR, Coursol CJ et al. Generic immunosuppression in solid organ transplantation: a Canadian perspective. Transplantation 2012: 93: 657.
-
(2012)
Transplantation
, vol.93
, pp. 657
-
-
Harrison, J.J.1
Schiff, J.R.2
Coursol, C.J.3
-
18
-
-
0033044557
-
Drug substitution in transplantation: A National Kidney Foundation White Paper
-
Sabatini S, Ferguson RM, Helderman JH, Hull AR, Kirkpatrick BS, Barr WH. Drug substitution in transplantation: A National Kidney Foundation White Paper. Am J Kidney Dis 1999: 33: 389.
-
(1999)
Am J Kidney Dis
, vol.33
, pp. 389
-
-
Sabatini, S.1
Ferguson, R.M.2
Helderman, J.H.3
Hull, A.R.4
Kirkpatrick, B.S.5
Barr, W.H.6
-
19
-
-
3242772986
-
Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation
-
Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet 2004: 43: 623.
-
(2004)
Clin Pharmacokinet
, vol.43
, pp. 623
-
-
Staatz, C.E.1
Tett, S.E.2
-
20
-
-
84867097632
-
A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients
-
Alloway RR, Sadaka B, Trofe-Clark J, Wiland A, Bloom RD. A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients. Am J Transplant 2012: 12: 2825.
-
(2012)
Am J Transplant
, vol.12
, pp. 2825
-
-
Alloway, R.R.1
Sadaka, B.2
Trofe-Clark, J.3
Wiland, A.4
Bloom, R.D.5
-
21
-
-
80054903174
-
Comparison of dose requirements of Sandoz™ generic tacrolimus with brand innovator drug in kidney transplant recipients
-
Abstract 1102.
-
Dick TB, Raines AA, van Der Werf W, Alonso D, Fujita S, Stinson JB. Comparison of dose requirements of Sandoz™ generic tacrolimus with brand innovator drug in kidney transplant recipients. Am J Transplant 2011: 11(S2): Abstract 1102.
-
(2011)
Am J Transplant
, vol.11
, Issue.S2
-
-
Dick, T.B.1
Raines, A.A.2
van Der Werf, W.3
Alonso, D.4
Fujita, S.5
Stinson, J.B.6
-
22
-
-
84873346720
-
Generic tacrolimus in renal transplantation: trough blood concentration as a surrogate marker for drug exposure
-
Connor A, Prowse A, MacPhee I, Rowe PA. Generic tacrolimus in renal transplantation: trough blood concentration as a surrogate marker for drug exposure. Transplantation 2012: 93: e45.
-
(2012)
Transplantation
, vol.93
-
-
Connor, A.1
Prowse, A.2
MacPhee, I.3
Rowe, P.A.4
-
25
-
-
84899951731
-
Use of de novo generic tacrolimus in liver transplantation is safe and effective but results in a change in prescribing behaviour which may reduce cost savings
-
Cheung M, Rodrigues S, Dannhorn E et al. Use of de novo generic tacrolimus in liver transplantation is safe and effective but results in a change in prescribing behaviour which may reduce cost savings. Liver Transpl 2013: 19: S149.
-
(2013)
Liver Transpl
, vol.19
-
-
Cheung, M.1
Rodrigues, S.2
Dannhorn, E.3
-
26
-
-
80052664899
-
A multicenter experience with generic tacrolimus conversion
-
McDevitt-Potter LM, Sadaka B, Tichy EM, Rogers CC, Gabardi S. A multicenter experience with generic tacrolimus conversion. Transplantation 2011: 92: 653.
-
(2011)
Transplantation
, vol.92
, pp. 653
-
-
McDevitt-Potter, L.M.1
Sadaka, B.2
Tichy, E.M.3
Rogers, C.C.4
Gabardi, S.5
-
27
-
-
80052259219
-
The impact of conversion from Prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function
-
Momper JD, Ridenour TA, Schonder KS, Shapiro R, Humar A, Venkataramanan R. The impact of conversion from Prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. Am J Transplant 2011: 11: 1861.
-
(2011)
Am J Transplant
, vol.11
, pp. 1861
-
-
Momper, J.D.1
Ridenour, T.A.2
Schonder, K.S.3
Shapiro, R.4
Humar, A.5
Venkataramanan, R.6
-
28
-
-
84899972777
-
-
The effect of generic substitution of tacrolimus in liver and kidney transplant recipients. TTS Congress Berlin, 2012. Abstract 9-PO17.
-
Raghu VK, Momper JD, Shonder K et al. The effect of generic substitution of tacrolimus in liver and kidney transplant recipients. TTS Congress Berlin, 2012. Abstract 9-PO17.
-
-
-
Raghu, V.K.1
Momper, J.D.2
Shonder, K.3
-
29
-
-
84899936535
-
®) substitution in kidney and pancreas transplantation
-
Abstract 1294.
-
®) substitution in kidney and pancreas transplantation. Am J Transplant 2012: 12(Suppl s3): Abstract 1294.
-
(2012)
Am J Transplant
, vol.12
, Issue.SUPPL S3
-
-
Betmouni, R.1
Bedi, R.2
Duncan, N.3
-
30
-
-
84899957205
-
-
Programmed switch of renal transplant recipients from branded to generic tacrolimus is safe, well-tolerated and cost effective. Presented at British Thoracic Society 2013. Abstract P20.
-
Shui KY, Rezk T, Henry J et al. Programmed switch of renal transplant recipients from branded to generic tacrolimus is safe, well-tolerated and cost effective. Presented at British Thoracic Society 2013. Abstract P20.
-
-
-
Shui, K.Y.1
Rezk, T.2
Henry, J.3
-
31
-
-
84871601273
-
Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system
-
Spence MM, Nguyen LM, Hui RL, Chan J. Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system. Pharmacotherapy 2012: 32: 981.
-
(2012)
Pharmacotherapy
, vol.32
, pp. 981
-
-
Spence, M.M.1
Nguyen, L.M.2
Hui, R.L.3
Chan, J.4
-
32
-
-
84899936309
-
-
Systematic conversion to generic tacrolimus in stable kidney transplant patients. Abstract presented at 13th International Conference of Therapeutic Drug Monitoring and Clinical Toxicology. Salt Lake City, UT
-
Rosenborg S, Nordström A, Almquist T, Wennberg L, Bárány P. Systematic conversion to generic tacrolimus in stable kidney transplant patients. Abstract presented at 13th International Conference of Therapeutic Drug Monitoring and Clinical Toxicology. Salt Lake City, UT, 2013.
-
(2013)
-
-
Rosenborg, S.1
Nordström, A.2
Almquist, T.3
Wennberg, L.4
Bárány, P.5
-
33
-
-
84899967361
-
-
Generic switch of tacrolimus in prevalent kidney transplant recipients. Abstract presented at ATC. Abstract A635.
-
Jogia P, Oskiera D, Booth S, McKane W. Generic switch of tacrolimus in prevalent kidney transplant recipients. Abstract presented at ATC 2013. Abstract A635.
-
(2013)
-
-
Jogia, P.1
Oskiera, D.2
Booth, S.3
McKane, W.4
-
34
-
-
84899979941
-
Short-term outcomes in heart transplant recipients treated with generic tacrolimus compared to Prograf
-
Dhungel V, Colvin-Adams MM, Eckman PM. Short-term outcomes in heart transplant recipients treated with generic tacrolimus compared to Prograf. Open J Organ Transpl Surg 2013: 3: 19.
-
(2013)
Open J Organ Transpl Surg
, vol.3
, pp. 19
-
-
Dhungel, V.1
Colvin-Adams, M.M.2
Eckman, P.M.3
-
35
-
-
84899955910
-
-
Summary of Product Characteristics. Adoport® 0.5 mg hard capsules. Available from: (accessed 1 June 2013).
-
Summary of Product Characteristics. Adoport® 0.5 mg hard capsules. Available from: www.emc.medicines.org.uk (accessed 1 June 2013).
-
-
-
-
36
-
-
84899947234
-
Transplant coordinators' perceived impact of availability of multiple generic immunosuppression therapies on patients, workload, and posttransplant maintenance therapy
-
doi: 10.1155/2013/897434. Epub 2013 Jan 8.
-
Parker K, Zagadailov EA, Bruno AS, Wiland AM. Transplant coordinators' perceived impact of availability of multiple generic immunosuppression therapies on patients, workload, and posttransplant maintenance therapy. J Transplant 2013: 2013: 897434. doi: 10.1155/2013/897434. Epub 2013 Jan 8.
-
(2013)
J Transplant
, vol.2013
, pp. 897434
-
-
Parker, K.1
Zagadailov, E.A.2
Bruno, A.S.3
Wiland, A.M.4
-
37
-
-
79954421083
-
Oral tacrolimus products: measures to reduce risk of medication errors
-
MHRA.
-
MHRA. Oral tacrolimus products: measures to reduce risk of medication errors. MHRA Drug Saf Update 2010: 3: 5.
-
(2010)
MHRA Drug Saf Update
, vol.3
, pp. 5
-
-
|