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Results for 'extrapolation'

A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation
OVN Avatar Jorge J. García, Luis E. Raez, Daniel Rosas
A narrative review of biosimilars: a continued journey from the scientific evidence to practice implementation

Biosimilars, interchangeability, extrapolation, immunogenicity

Biologic agents have significantly improved the management of serious health conditions over the last two decades, offering better treatment outcomes and quality of life compared to traditional chemotherapy. The cost of biologic drugs is high, leading to increased healthcare expenses. This mirror…

Aug 3rd • 10 mins read

Biosimilars: what the oncologist should know
OVN Avatar Marc Thill, Nicholas Thatcher, Vladimir Hanes & Gary H. Lyman
Biosimilars: what the oncologist should know

biosimilars, extrapolation, monoclonal antibodies, oncologic biosimilars

As originator biologic medicines lose patent protection, biopharmaceutical companies are developing biosimilars. Biosimilars are similar versions of costly and complex therapies aimed at providing more affordable treatment options. Many biosimilars are now approved worldwide, with several m…

Dec 18th • 25 mins read

In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018
OVN Avatar Jingjing Yu, Isabelle Ragueneau-Majlessi
In Vitro-to-In Vivo Extrapolation of Transporter Inhibition Data for Drugs Approved by the US Food and Drug Administration in 2018

In Vitro-to-In Vivo, Transporter Inhibition Data, Drug Approval, FDA, 2018

The analysis focuses on inhibition transporter data from New Drug Applications approved by the FDA in 2018, involving 42 drugs. Key points include: In vitro-to-in vivo predictions were available for nine recommended transporters. 29 parent drugs and 16 metabolites inhibited at least one transpor…

Jan 25th • 12 mins read

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