Results 111 to 120 of about 31,601 (273)

Model‐Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia

open access: yesClinical Pharmacology &Therapeutics, Volume 119, Issue 2, Page 322-335, February 2026.
Model‐informed drug development (MIDD) played a crucial role in the successful development and regulatory approval of daprodustat, a novel oral hypoxia‐inducible factor prolyl hydroxylase (HIF‐PHI) inhibitor aimed at treating anemia in chronic kidney disease patients.
Kelly M. Mahar   +6 more
wiley   +1 more source

Six‐Year Trends in Real‐World Data Use for Post‐Marketing Surveillance of New Medical Products in Japan

open access: yesClinical and Translational Science, Volume 19, Issue 2, February 2026.
ABSTRACT The Ministerial Ordinance on Good Post‐Marketing Study Practice for Drugs was amended by the Ministry of Health, Labour and Welfare (MHLW) in 2018 to clearly define post‐marketing database studies (DBS) as a measure of pharmacovigilance activities for approved medical products in Japan.
Suguru Okami   +2 more
wiley   +1 more source

Ten years of clinical experience with biosimilar human growth hormone: a review of safety data

open access: yesDrug Design, Development and Therapy, 2017
Maria Victoria Borrás Pérez,1 Berit Kriström,2 Tomasz Romer,3 Mieczyslaw Walczak,4 Nadja Höbel,5 Markus Zabransky5 1Hospital General de Granollers, Granollers, Barcelona, Spain; 2Department of Clinical Sciences, Pediatrics, Ume ...
Borrás Pérez MV   +5 more
doaj  

Innovator ranibizumab ComparEd to Biosimilar ranibizumab in combination with Expansile gas in submaculaR HemorrhaGe: the ICEBERG study

open access: yesBMC Ophthalmology
Purpose To compare the anatomical and visual outcomes in eyes with submacular hemorrhage (SMH) treated with a combination of ranibizumab (RBZ) either innovator or biosimilar (Razumab) and intravitreal perfluoropropane gas (C3F8).
Debdulal Chakraborty   +8 more
doaj   +1 more source

Biosimilars [PDF]

open access: yesZeitschrift für Rheumatologie, 2013
M. Aringer, T. Dörner
  +5 more sources

Biosimilars Have Arrived: Rituximab [PDF]

open access: hybrid, 2018
Maria Greenwald   +2 more
openalex   +1 more source

Outcomes of an Intravenous to Subcutaneous Infliximab (CT‐P13) Strategy in Takayasu Arteritis: A Proof‐of‐Concept Prospective Study

open access: yesACR Open Rheumatology, Volume 8, Issue 1, January 2026.
Objectives To evaluate persistence, outcomes, safety, and remission maintenance after switching from intravenous infliximab (IV‐IFX) to subcutaneous infliximab (SC‐IFX, CT‐P13) in patients with Takayasu arteritis (TA). Methods We conducted a prospective, single‐center, proof‐of‐concept observational study of consecutive adults with TA in sustained ...
Luca Iorio   +6 more
wiley   +1 more source

A comparative analysis of biosimilar vs. originator filgrastim in combination with plerixafor for stem cell mobilization in lymphoma and multiple myeloma: a propensity‐score weighted multicenter approach [PDF]

open access: bronze, 2017
Francesco Lanza   +12 more
openalex   +1 more source

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