Risk Focus, Bolstering De Novo Could Remedy 510 (k) Woes

B Moscovitch - Inside Washington's FDA Week, 2010 - JSTOR
… Naples, FL — Leading opponents of the biosimilars policy included in health reform … ” on
health care reform, their analysis of the biosimilars debate echoes broader concerns about how …

[图书][B] Endotoxin detection and control in pharma, limulus, and mammalian systems

KL Williams - 2019 - books.google.com
… [49] The legal basis for biosimilars in the EU is found in “Article 6 of … characterization methods,
the idea of an “identical copy” is not an acceptable one for pairing biologics and biosimilars

Seizing the strategic opportunities of emerging technologies by building up innovation system: monoclonal antibody development in China

MY Zhang, J Li, H Hu, YT Wang - Health research policy and systems, 2015 - Springer
… above, we conducted the data analysis in two stages. First, … in terms of the seven dimensions
as defined above. Such an … are diversified and developed as biosimilar to the foreign …

[PDF][PDF] The Oncology horizon scanning project

W Van Dyck, T Geldof - Vlerick HMC Report, 2015 - academia.edu
… or entrance of biosimilars after patent expiries. … a process analysis of the present market
authorization and reimbursement process. We complemented this with a systematic review of …

Development and application of quality measures of clinical pharmacist services provided in inpatient/acute care settings

NM Acquisto, CJ Beavers, S Bolesta… - Journal of the …, 2021 - Wiley Online Library
… The Donabedian model has served as a systematic, holistic guide to measuring health
care quality that encompasses three main types of quality measures: structural characteristics, …

Concepts and applications of “natural computing” techniques in de novo drug and peptide design

JA Hiss, M Hartenfeller… - Current pharmaceutical …, 2010 - ingentaconnect.com
… entities (NCEs) that were approved by the Food and Drug Administration (USA) are of
natural product origin [1], and there is a rapidly growing market for biologics and biosimilars, ie …

[HTML][HTML] The advancement of artificial intelligence in biomedical research and health innovation: challenges and opportunities in emerging economies

RGL da Silva - Globalization and Health, 2024 - ncbi.nlm.nih.gov
… in all versions of the manuscript concept and design, literature review, and interpretation of
data. Since this is a debate article, no empirical data collection and analysis was performed. …

Challenges for the optimization of drug therapy in the treatment of cancer

N Carels, AJ Conforte, CR Lima… - Networks in Systems …, 2020 - Springer
… specific characteristics). By contrast, the commonly accepted … that is informed by a systematic
review of evidence and an … few circumstances in which two biosimilar agents are directly …

From biologics to biosimilars and biobetters–democratization of high-end therapeutics

SG Honavar - Indian journal of ophthalmology, 2021 - journals.lww.com
… The European Union (EU) adapted a framework for biosimilars in 2004, which paved the
way to the approval of the first biosimilar human recombinant growth hormone, Omnitrope (…

Liquid biopsy and NSCLC

D Trombetta, A Sparaneo, FP Fabrizio… - Lung Cancer …, 2016 - Future Medicine
… The term ‘liquid biopsy’ is strictly referred to a blood test used for the isolation and characterization
… features, by analogy to the definition of a ‘tissue’ biopsy. From a more general point of …