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 …
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…
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
… 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 …
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 …
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
… 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, …
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 …
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. …
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 …
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 (…
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 …
… features, by analogy to the definition of a ‘tissue’ biopsy. From a more general point of …