Petra Glander - Academia.edu (original) (raw)
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Papers by Petra Glander
Transplantation Proceedings, Aug 1, 2002
Value in Health, Nov 1, 2012
Transplantation, Jul 27, 2008
Transplantation Proceedings, Nov 1, 2001
The Journal of Clinical Pharmacology, Jul 1, 2007
ABSTRACT
Clinical Journal of The American Society of Nephrology, Mar 1, 2010
Nieren-und Hochdruckkrankheiten, Jun 1, 2007
Nephrology Dialysis Transplantation, May 1, 2021
Transplantation Proceedings, Dec 1, 2018
Transplantation, Apr 15, 2011
Transplantation Proceedings, Aug 1, 2002
Transplantation, Feb 1, 2007
ABSTRACT
Nephrology Dialysis Transplantation, May 1, 2016
Transplantation, Jul 1, 2010
Transplantation, Jul 1, 2004
American Journal of Transplantation, Apr 1, 2007
The aim of this single‐center crossover substudy was to assess pharmacokinetics and pharmacodynam... more The aim of this single‐center crossover substudy was to assess pharmacokinetics and pharmacodynamics [inosine 5′‐monophosphate dehydrogenase (IMPDH) activity] of enteric‐coated mycophenolate sodium (EC‐MPS) and mycophenolate mofetil (MMF) at steady‐state conditions. Stable maintenance renal transplant patients on 1 g MMF b.i.d. participating in a double‐blind, multicenter study, were randomized to receive EC‐MPS (720 mg b.i.d.) or continue receiving MMF (1000 mg b.i.d.) for 12 months. Thereafter, all patients (n = 18) received 720 mg EC‐MPS b.i.d. Area under the plasma mycophenolic acid (MPA) concentration–time curve with EC‐MPS (57.4 ± 15.0 μg h/mL) fulfilled bioequivalence criteria (geometric mean 0.98 (90% CI: 0.87–1.11) compared to MMF (58.4 ± 14.1 μg h/mL). Consistent with the delayed release characteristics of EC‐MPS, peak MPA concentration (geometric mean 0.89; 90% CI: 0.70–1.13) occurred approximately 0.5 h later (p < 0.05) and predose MPA levels (geometric mean 2.10; 90% CI: 1.51–2.91) were higher and more variable, not fulfilling bioequivalence criteria. IMPDH activity inversely followed MPA concentrations and was inhibited to a similar degree (approximately 85%) by both formulations. The calculated value for 50% IMPDH inhibition was identical for both drugs. In conclusion, equimolar doses of EC‐MPS and MMF produce equivalent MPA exposure, while the delayed release formulation of EC‐MPS exhibits more variable predose levels and Tmax. Overall, IMPDH activity reflected MPA pharmacokinetics.
Nephrology Dialysis Transplantation, 2018
Nephrology Dialysis Transplantation, 2019
Transplantation Proceedings, Aug 1, 2002
Value in Health, Nov 1, 2012
Transplantation, Jul 27, 2008
Transplantation Proceedings, Nov 1, 2001
The Journal of Clinical Pharmacology, Jul 1, 2007
ABSTRACT
Clinical Journal of The American Society of Nephrology, Mar 1, 2010
Nieren-und Hochdruckkrankheiten, Jun 1, 2007
Nephrology Dialysis Transplantation, May 1, 2021
Transplantation Proceedings, Dec 1, 2018
Transplantation, Apr 15, 2011
Transplantation Proceedings, Aug 1, 2002
Transplantation, Feb 1, 2007
ABSTRACT
Nephrology Dialysis Transplantation, May 1, 2016
Transplantation, Jul 1, 2010
Transplantation, Jul 1, 2004
American Journal of Transplantation, Apr 1, 2007
The aim of this single‐center crossover substudy was to assess pharmacokinetics and pharmacodynam... more The aim of this single‐center crossover substudy was to assess pharmacokinetics and pharmacodynamics [inosine 5′‐monophosphate dehydrogenase (IMPDH) activity] of enteric‐coated mycophenolate sodium (EC‐MPS) and mycophenolate mofetil (MMF) at steady‐state conditions. Stable maintenance renal transplant patients on 1 g MMF b.i.d. participating in a double‐blind, multicenter study, were randomized to receive EC‐MPS (720 mg b.i.d.) or continue receiving MMF (1000 mg b.i.d.) for 12 months. Thereafter, all patients (n = 18) received 720 mg EC‐MPS b.i.d. Area under the plasma mycophenolic acid (MPA) concentration–time curve with EC‐MPS (57.4 ± 15.0 μg h/mL) fulfilled bioequivalence criteria (geometric mean 0.98 (90% CI: 0.87–1.11) compared to MMF (58.4 ± 14.1 μg h/mL). Consistent with the delayed release characteristics of EC‐MPS, peak MPA concentration (geometric mean 0.89; 90% CI: 0.70–1.13) occurred approximately 0.5 h later (p < 0.05) and predose MPA levels (geometric mean 2.10; 90% CI: 1.51–2.91) were higher and more variable, not fulfilling bioequivalence criteria. IMPDH activity inversely followed MPA concentrations and was inhibited to a similar degree (approximately 85%) by both formulations. The calculated value for 50% IMPDH inhibition was identical for both drugs. In conclusion, equimolar doses of EC‐MPS and MMF produce equivalent MPA exposure, while the delayed release formulation of EC‐MPS exhibits more variable predose levels and Tmax. Overall, IMPDH activity reflected MPA pharmacokinetics.
Nephrology Dialysis Transplantation, 2018
Nephrology Dialysis Transplantation, 2019