Results 51 to 60 of about 31,601 (273)

Imbalanced machine learning classification models for removal biosimilar drugs and increased activity in patients with rheumatic diseases.

PLoS ONE, 2023
ObjectivePredict long-term disease worsening and the removal of biosimilar medication in patients with rheumatic diseases.MethodologyObservational, retrospective descriptive study.
David Castro Corredor, Luis Ángel Calvo Pascual   +1 more
doaj   +1 more source

Fostering medication review competence of pharmacy students: An assessment by students and their preceptors after advanced‐level practical internship

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study was to introduce a new assessment method for pharmacy students' real‐life competence in reviewing medications after obligatory advanced‐level practical internship in Finland. Methods The new medication review (MR) competence assessment method consisted of (1) a self‐assessment by pharmacy students and (2) a performance ...
Katja Leiman, Aleksi Westerholm, Tero Vahlberg, Noora Lias, Tanja Lindholm, Marja Airaksinen   +5 more
wiley   +1 more source

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

, 2016
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
core   +2 more sources

Biosimilar G-CSF versus filgrastim and lenograstim in healthy unrelated volunteer hematopoietic stem cell donors [PDF]

, 2017
The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two
Bogusz, K, Farhan, R, Krol, M, Krol, M, Piotrowska, I, Skwierawska, K, Snarski, E, Torosian, T, Urbanowska, E, Wiktor-Jedrzejczak, W, Zborowska, H   +10 more
core   +1 more source

A Review on Quantitative Process Analytical Technology for Continuous Downstream Processing of Monoclonal Antibodies

Biotechnology and Bioengineering, EarlyView.
ABSTRACT The competition in the biopharmaceutical market is increasing due to the market entry of biosimilars and rising costs in research and development of new drugs. Hence, continuous manufacturing gained significant attention due to its potential in reducing production cycle times and costs, as well as the possibility of real‐time release testing ...
Mariana Carvalho, Ana Cruz, Cees Haringa, Marcel Ottens, Marieke Klijn   +4 more
wiley   +1 more source

Lab‐Scale Continuous Biomanufacturing: A Tool for Process Development With Adaptive Strategies for Capture and Virus Inactivation

Biotechnology and Bioengineering, EarlyView.
Schematic representation of the continuous lab‐scale process. ABSTRACT Monoclonal antibodies (mAbs) are nowadays fundamental in treating a wide range of severe diseases, including cancer, infections, or autoimmune disorders. Due to their high specificity, potent activity, and fewer side effects compared to small molecular drugs, the market for mAbs is ...
Thomas Kruse, Fabian Schmitz, Janina Kilian, Jonas Austerjost, Lucas‐Nik Reger, Markus Kampmann   +5 more
wiley   +1 more source

Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA

Биопрепараты: Профилактика, диагностика, лечение, 2019
European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul ...
A. A. Soldatov, Zh. I. Avdeeva, V. P. Bondarev, V. D. Mosyagin   +3 more
doaj   +1 more source

Long term efficacy, safety and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort [PDF]

, 2018
K
Banai, János, Bene, László, Farkas, Klaudia, Gasztonyi, Beáta, Gecse, Krisztina B., Golovics, Petra Anna, Gönczi, Lóránt, Kristóf, Tünde, Kürti, Zsuzsanna, Lakatos, László, Lakatos, Péter László, Lovász, Barbara Dorottya, Miheller, Pál, Molnár, Tamás, Nagy, Ferenc, Palatka, Károly, Papp, Mária, Patai, Árpád, Rutka, Mariann, Salamon, Ágnes, Szalay, Balázs, Szamosi, Tamás, Szepes, Zoltán, Tóth, Gábor Tamás, Vincze, Áron, Végh, Zsuzsanna   +25 more
core   +1 more source

Artificial intelligence and machine learning‐assisted digital applications for biopharmaceutical manufacturing

Biotechnology Progress, EarlyView.
Abstract Artificial intelligence and automation are no longer just buzzwords in the biopharmaceutical industry. The manufacturing of a class of biologics, comprising monoclonal antibodies, cell therapies, and gene therapies, is far more complex than that of traditional small molecule drugs.
Shyam Panjwani, Hao Wei, John Mason
wiley   +1 more source

Efficacy and Safety of Bevacizumab Biosimilar (Encoda) Compared With Reference Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer: A Multicenter, Real-World Study

Clinical Medicine Insights: Oncology
Background: The bevacizumab biosimilar (Encoda), which was approved by the National Medical Products Administration (NMPA) in China in 2019, is a biosimilar of bevacizumab.
Han Shan, Mengmeng Wang, Shuohan Huang, Hongyue Liu, Jiyong Liu, Qiong Du   +5 more
doaj   +1 more source