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Extrapolation in Practice: Lessons from 10 Years with Biosimilar Filgrastim

Biosimilar filgrastim (Sandoz) was approved in Europe in 2009 and, in 2015, was the first biosimilar approved in the USA. These authorizations were based on the “totality of evidence” concept, an approach that considers data from structural and functional characterization and comparability analysis and non-clinical and clinical studies. For biosimilar filgrastim, phase III...

Correction to: Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

, Genolier , Switzerland 2 & Andriy Krendyukov 3 Department of Hematology-Oncology, Hospital Cl ́ınic de Barcelona, University of Barcelona , Barcelona , Spain 4 Sandoz Biopharmaceuticals, Sandoz International

Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years’ Experience Gained

Genolier , Genolier , Switzerland 2 & Andriy Krendyukov 3 Department of Hematology-Oncology, Hospital Cl ́ınic de Barcelona, University of Barcelona , Barcelona , Spain 4 Sandoz Biopharmaceuticals, Sandoz

Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?

, London , UK 2 & Andriy Krendyukov 3 Universite ́ de Bordeaux , INSERM 1026, Bordeaux , France 4 Service de Ne ́phrologie Transplantation Dialyse Aphe ́re`se, Centre Hospitalier Universitaire de Bordeaux

Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study

PurposeIn the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations.MethodsMONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European...