Publications by authors named "Peter Bias"

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The Path Towards a Tailored Clinical Biosimilar Development.
Martin Schiestl, Gopinath Ranganna, Keith Watson, Byoungin Jung, Karsten Roth, Peter Bias

BioDrugs· June 2020

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A Phase 2, International, Multicenter, Open-label Clinical Trial of Subcutaneous Tbo-Filgrastim in Pediatric Patients With Solid Tumors Undergoing Myelosuppressive Chemotherapy.
Noah Federman, Monica D Dragomir, Zoryana Kizyma, Jelena Roganovic, Peter Bias

J Pediatr Hematol Oncol· October 2019

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A pharmacokinetic study of lipegfilgrastim in children with Ewing family of tumors or rhabdomyosarcoma.
Margarita B Belogurova, Zoryana P Kizyma, Miklós Garami, Mónika Csóka, Michael J Lamson, Peter Bias

Cancer Chemother Pharmacol· January 2017

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Efficacy and safety of lipegfilgrastim compared with placebo in patients with non-small cell lung cancer receiving chemotherapy: post hoc analysis of elderly versus younger patients.
Constantin Volovat, Igor Bondarenko, Oleg Gladkov, Anton Buchner, Andreas Lammerich, Peter Bias

Support Care Cancer· December 2016

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Comment on "Biosimilar FSH preparations- are they identical twins or just siblings?".
Thomas Strowitzki, Waldemar Kuczynski, Arnd Mueller, Peter Bias

Reprod Biol Endocrinol· September 2016

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Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor.
Ruth Pettengell, Peter Bias, Udo Mueller, Nicole Lang

Support Care Cancer· June 2016

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Safety and efficacy of Ovaleap® (recombinant human follicle-stimulating hormone) for up to 3 cycles in infertile women using assisted reproductive technology: a phase 3 open-label follow-up to Main Study.
Thomas Strowitzki, Waldemar Kuczynski, Arnd Mueller, Peter Bias

Reprod Biol Endocrinol· June 2016

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Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study.
Andreas Lammerich, Peter Balcke, Peter Bias, Simone Mangold, Martin Wiesholzer

Clin Ther· February 2016

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Chemotherapy-associated treatment burden in breast cancer patients receiving lipegfilgrastim or pegfilgrastim: secondary efficacy data from a phase III study.
Oleg A Gladkov, Anton Buchner, Peter Bias, Udo Müller, Reiner Elsässer

Support Care Cancer· January 2016

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Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART).
Thomas Strowitzki, Waldemar Kuczynski, Arnd Mueller, Peter Bias

Reprod Biol Endocrinol· January 2016

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Phase I, two-way, crossover study to demonstrate bioequivalence and to compare safety and tolerability of single-dose XM17 vs Gonal-f® in healthy women after follicle-stimulating hormone downregulation.
Andreas Lammerich, Arnd Mueller, Peter Bias

Reprod Biol Endocrinol· December 2015

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Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in patients with non-small cell lung cancer receiving myelosuppressive therapy.
Constantin Volovat, Igor M Bondarenko, Oleg A Gladkov, Reiner Elsässer, Anton Buchner, Peter Bias

Springerplus· July 2015

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Phase 1 safety, tolerability, and pharmacokinetic study of single ascending doses of XM17 (recombinant human follicle-stimulating hormone) in downregulated healthy women.
Andreas Lammerich, Peter Bias, Beate Gertz

Int J Womens Health· July 2015

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Phase II dose-finding study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy.
Oleg Gladkov, Vladimir Moiseyenko, Igor N Bondarenko, Yaroslav Shparyk, Steven Barash, Peter Bias

Med Oncol· June 2015

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Lipegfilgrastim: pharmacodynamics and pharmacokinetics for body-weight-adjusted and 6 mg fixed doses in two randomized studies in healthy volunteers.
Anton Buchner, Andreas Lammerich, Afsaneh Abdolzade-Bavil, Udo Müller, Peter Bias

Curr Med Res Opin· December 2014

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A randomized, double-blind, active control, multicenter, dose-finding study of lipegfilgrastim (XM22) in breast cancer patients receiving myelosuppressive therapy.
Anton Buchner, Reiner Elsässer, Peter Bias

Breast Cancer Res Treat· November 2014

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Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy.
Constantin Volovat, Oleg A Gladkov, Igor M Bondarenko, Steve Barash, Anton Buchner, Peter Bias

Clin Breast Cancer· April 2014

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Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy.
Igor Bondarenko, Oleg A Gladkov, Reiner Elsaesser, Anton Buchner, Peter Bias

BMC Cancer· August 2013

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Epoetin Theta with a New Dosing Schedule in Anaemic Cancer Patients Receiving Nonplatinum-Based Chemotherapy: A Randomised Controlled Trial.
Sergei A Tjulandin, Peter Bias, Reiner Elsässer, Beate Gertz, Erich Kohler

Arch Drug Inf· September 2011

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Epoetin Theta in Anaemic Cancer Patients Receiving Platinum-Based Chemotherapy: A Randomised Controlled Trial.
Sergei A Tjulandin, Peter Bias, Reiner Elsässer, Beate Gertz, Erich Kohler

Arch Drug Inf· September 2010

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Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin's lymphoma.
Andreas Engert, Auro del Giglio, Peter Bias, Heinz Lubenau, Ulrich Gatzemeier

Onkologie· October 2009

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Analysis of the precision and sensitivity to change of different approaches to assess cartilage loss by quantitative MRI in a longitudinal multicentre clinical trial in patients with knee osteoarthritis.
Jean-Pierre Raynauld, Johanne Martel-Pelletier, François Abram, Marc Dorais, Boulos Haraoui, Peter Bias

Arthritis Res Ther· August 2009

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Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial.
Heinz Lubenau, Peter Bias, Anne-Katrin Maly, Karl Ernst Siegler, Kai Mehltretter

BioDrugs· June 2009

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6-thioguanine nucleotide-adapted azathioprine therapy does not lead to higher remission rates than standard therapy in chronic active crohn disease: results from a randomized, controlled, open trial.
Max Reinshagen, Ekkehard Schütz, Victor W Armstrong, Christoph Behrens, Christian von Tirpitz, Peter Bias

Clin Chem· July 2007

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Association of inosine triphosphatase 94C>A and thiopurine S-methyltransferase deficiency with adverse events and study drop-outs under azathioprine therapy in a prospective Crohn disease study.
Nicolas von Ahsen, Victor W Armstrong, Christoph Behrens, Christian von Tirpitz, Andreas Stallmach, Peter Bias

Clin Chem· December 2005

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