Results 71 to 80 of about 22,015 (248)

More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Traditionally, clinical outcomes measuring how a patient feels, functions, or survives are preferred endpoints in clinical trials; however, some may take a long time to manifest in slowly developing diseases. Biomarkers, if properly validated, can serve as surrogate endpoints, acting as substitutes for clinical outcomes.
Renske Johanna Grupstra   +4 more
wiley   +1 more source

Charge Variants of an Avastin Biosimilar Isolation, Characterization, In Vitro Properties and Pharmacokinetics in Rat. [PDF]

open access: yesPLoS ONE, 2016
The similarity between a proposed biosimilar product and the reference product can be affected by many factors. This study is designed to examine whether any subtle difference in the distribution of the charge variants of an Avastin biosimilar can affect
Yan-Yan Zhao   +5 more
doaj   +1 more source

Market Access Analysis of Biologics and Small-Molecule Inhibitors for Inflammatory Bowel Disease Among US Health Insurance Policies. [PDF]

open access: yes, 2019
BACKGROUND AND AIMS:Treatment pathways for ulcerative colitis (UC) and Crohn's disease (CD) are shifting to a more individualized, risk-stratified approach.
Cao, Charlie   +5 more
core  

Financial Toxicity Associated with Biological Medicines: A Scoping Review

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Financial toxicity, defined as the economic burden experienced by patients due to medication and other healthcare costs and their consequences, such as material, psychosocial and behavioral effects, represents a significant concern for individuals receiving biological medicines.
Laura Sara Maria Saarukka   +4 more
wiley   +1 more source

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

open access: yesPharmaceuticals, 2020
Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region.
Evelien Moorkens   +8 more
doaj   +1 more source

Bioengineering of rFVIIa Biopharmaceutical and Structure Characterization for Biosimilarity Assessment [PDF]

open access: yes, 2018
Eptacog alfa (NovoSeven®) is a vitamin K-dependent recombinant Factor VIIa produced by genetic engineering from baby hamster kidney (BHK) cells as a single peptide chain of 406 residues. After activation, it consists of a light chain (LC) of 152 amino
Eravci, Murat   +7 more
core   +2 more sources

Policy Networks and Policy Entrepreneurship in the EU: Explaining Structural Policy Change in Pharmaceutical Innovation Incentives and Health Technology Assessment

open access: yesEuropean Policy Analysis, EarlyView.
ABSTRACT Policy process research has excelled in explaining structural policy change within national settings, but extensions and applications to the EU level have long proven challenging for scholars. Given that the EU is currently experiencing its longest period of Treaty stability since the 1980s—having evolved into a sui generis political system ...
Vassilis Karokis‐Mavrikos
wiley   +1 more source

THE NOVEL BIOSIMILAR OF FOLLITROPIN ALPHA TO BE MANUFACTURED IN RUSSIA STARTING FROM 2017

open access: yesАкушерство, гинекология и репродукция, 2017
Within the framework of the 27th international conference «Reproductive technologies today and tomorrow», the first Russia-made follitropin alfa biosimilar for controlled ovarian stimulation in assisted reproductive technologies (ART) was presented.
I. I. Vorobiev   +2 more
doaj   +1 more source

Disparity in the Markers of Affordability Across Targeted‐ and Immune‐Therapy Drugs Used in Head and Neck Cancers

open access: yesHead &Neck, EarlyView.
ABSTRACT Background The expanding use of systemic therapies for recurrent and metastatic head and neck cancer has raised major concerns regarding affordability and equitable access, particularly across countries with differing income levels and health financing structures.
Arjun Gurmeet Singh   +9 more
wiley   +1 more source

A Comparison between Recombinant Activated Factor VII (Aryoseven) and Novoseven in Patients with Congenital Factor VII Deficiency [PDF]

open access: yes, 2015
In order to establish the efficacy and biosimilar nature of AryoSeven to NovoSeven in the treatment of congenital factor VII (FVII) deficiency, patients received either agent at 30 1/4g/kg, intravenously per week for 4 weeks, in a randomized fashion. The
Abolghasemi, H.   +16 more
core  

Home - About - Disclaimer - Privacy