Bruno Reigner
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View article: Model‐based approach for methoxy polyethylene glycol‐epoetin beta drug development in paediatric patients with anaemia of chronic kidney disease
Model‐based approach for methoxy polyethylene glycol‐epoetin beta drug development in paediatric patients with anaemia of chronic kidney disease Open
Aims Methoxy polyethylene glycol‐epoetin beta (continuous erythropoietin receptor activator, C.E.R.A.) is used for the treatment of anaemia in adults with chronic kidney disease (CKD). Patients treated with shorter‐acting erythropoiesis‐st…
View article: Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil
Generics in transplantation medicine: Randomized comparison of innovator and substitution products containing mycophenolate mofetil Open
Physicians in the field of transplantation should be aware of the potential risk of altering the therapeutic outcome when switching from one preparation of MMF to another. ClinicalTrials.gov identifier: NCT02981290.
View article: P17 Clinical evidence supported by a model-based approach and real world data for the development of c.e.r.a. (continuous erythropoietin receptor activator) in pediatric patients with anemia due to chronic kidney disease
P17 Clinical evidence supported by a model-based approach and real world data for the development of c.e.r.a. (continuous erythropoietin receptor activator) in pediatric patients with anemia due to chronic kidney disease Open
Background C.E.R.A. indicated in Chronic Kidney Disease adult patients to correct and maintain hemoglobin (Hb) levels is approved in Europe and US since 2007; pediatric development is ongoing. A 20-week open-label Phase II study (NH19707) …
View article: Pediatric Dosing of Ganciclovir and Valganciclovir: How Model‐Based Simulations Can Prevent Underexposure and Potential Treatment Failure
Pediatric Dosing of Ganciclovir and Valganciclovir: How Model‐Based Simulations Can Prevent Underexposure and Potential Treatment Failure Open
Intravenous ganciclovir and oral valganciclovir are effective in the prevention and treatment of pediatric cytomegalovirus ( CMV ) infection but various dosing regimens are used in medical practice. Population pharmacokinetic (PopPK) model…
View article: Development of a physiologically based pharmacokinetic model for mefloquine and its application alongside a clinical effectiveness model to select an optimal dose for prevention of malaria in young Caucasian children
Development of a physiologically based pharmacokinetic model for mefloquine and its application alongside a clinical effectiveness model to select an optimal dose for prevention of malaria in young Caucasian children Open
Aims To predict the optimal chemoprophylactic dose of mefloquine in infants of 5–10 kg using physiologically based pharmacokinetic (PBPK) and clinical effectiveness models. Methods The PBPK model was developed in Simcyp version 14.1 and ve…