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The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable [PDF]

open access: yesAdvances in Therapy, 2021
In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator.
Daniel Furtner   +2 more
exaly   +5 more sources

Safety, Immunogenicity and Interchangeability of Biosimilar Monoclonal Antibodies and Fusion Proteins: A Regulatory Perspective

open access: yesDrugs, 2021
Biosimilars have been used for 15 years in the European Union (EU), and have been shown to reduce costs and increase access to important biological medicines.
Pekka Kurki, Elena Wolff-holz, Hein Raat
exaly   +2 more sources

The Paradox of Employee–Volunteer Interchangeability in a Supported Social Enterprise

open access: yesJournal of Public and Nonprofit Affairs, 2021
This research examines the paradox of employee–volunteer interchangeability as a core resource in a nonprofit social enterprise organization. Specifically, the research investigates a) how the human and social capital derived from employee–volunteer ...
Kunle Akingbola
exaly   +3 more sources

INTERCHANGEABILITY AND STANDARDIZATION OF THE PARAMETERS OF COMBUSTIBLE GASES WHEN USING HYDROGEN

open access: yesArchitecture and Engineering, 2022
Introduction and purpose of the study: The paper presents results of studies aimed to provide a rationale for the possibility of a gradual transition to hydrogen combustion in gas supply to domestic and commercial consumers without changes in the design ...
Alexander Shkarovskiy   +2 more
doaj   +2 more sources

Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States?

open access: yesBioDrugs, 2020
A biosimilar is a biologic drug that is “highly similar to a reference (originator) product, with no clinically meaningful differences between the two products in safety, purity, and potency”.
Jonathan Kay
exaly   +2 more sources

Interchangeability of vaccines

open access: bronzeThe Pediatric Infectious Disease Journal, 2001
The delivery of childhood immunizations can be complex, often requiring numerous injections over months or years to complete the recommended schedule. The ability to interchange similar vaccines from different manufacturers during a vaccination series is important because the product administered previously may be unknown or no longer available.The ...
Sandor Feldman
openalex   +3 more sources

Assessment of interchangeability rate between 2 methods of measurements

open access: yesMedicine (United States), 2018
The Bland–Altman (BA) and percentage error (PE) methods have been previously described to assess the agreement between 2 methods of medical or laboratory measurements.
Emmanuel Lorne
exaly   +2 more sources

Device interchangeability on anterior chamber depth and white-to-white measurements: a thorough literature review

open access: yesInternational Journal of Ophthalmology, 2016
We have reviewed a set of recently published studies that compared the anterior chamber depth (ACD) and/or white-to-white (WTW) distance obtained by means of different measuring devices.
José Vicente García-marqués   +1 more
exaly   +2 more sources

Correlation and Interchangeability of Venous and Capillary Blood Gases in Non-Critically Ill Neonates

open access: yesFrontiers in Pediatrics, 2018
BackgroundVenous blood gas (VBG) is frequently used in the neonatal unit as alternative for capillary blood gas (CBG). However, studies reporting correlation are conflicting and data on interchangeability in neonates are lacking.ObjectiveWe investigated ...
Enrico Lopriore, Arjan B Te Pas
exaly   +3 more sources

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