Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Joseph E. Mcclellan"'
Autor:
Joseph E. McClellan, Sesselja Ómarsdóttir, Nivedita Roy, Verena Berger, Cecilia Michel, Fausto Berti
Publikováno v:
Therapeutic Advances in Chronic Disease, Vol 15 (2024)
The development of a biosimilar is based on comparative structural, physicochemical, functional and clinical assessments. The sum of these analyses encompasses the ‘totality of evidence’, which demonstrates no clinically meaningful differences be
Externí odkaz:
https://doaj.org/article/9345a240043548c98ca554204428df9d
Autor:
Joseph E. McClellan, Hugh D. Conlon, Michael W. Bolt, Vatche Kalfayan, Rameshraja Palaparthy, Muhammad I. Rehman, Carol F. Kirchhoff
Publikováno v:
Therapeutic Advances in Gastroenterology, Vol 12 (2019)
The ‘totality-of-the-evidence’ biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinically meaningful differences in quality, safety, o
Externí odkaz:
https://doaj.org/article/d82d4499c3894b70bf09690ad77511ad
Autor:
Ramesh Palaparthy, D. Yin, Muhammad I. Rehman, Joseph E. McClellan, Steven Y. Hua, Chandrasekhar Udata, Chun-Hua Cai, S. Salts, Xu Meng
Background: To demonstrate pharmacokinetic (PK) similarity of PF-06438179/GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::815a133e2798e1511442ea5a6bd4f7eb
Autor:
Carol F. Kirchhoff, Joseph E. McClellan, Michael W. Bolt, Vatche Kalfayan, Muhammad I. Rehman, Rameshraja Palaparthy, Hugh D. Conlon
Publikováno v:
Therapeutic Advances in Gastroenterology, Vol 12 (2019)
Therapeutic Advances in Gastroenterology
Therapeutic Advances in Gastroenterology
The ‘totality-of-the-evidence’ biosimilarity concept requires that sufficient structural, functional, nonclinical, and clinical data are acquired in a stepwise manner, to demonstrate that no clinically meaningful differences in quality, safety, o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac58a5a0cd3a3a4dda361164cdc5e284
https://doi.org/10.1177/1756284819852535
https://doi.org/10.1177/1756284819852535
Publikováno v:
Seminars in arthritis and rheumatism. 45
Objective To provide an overview of the underlying scientific principles and standards for developing a biosimilar product. Methods An Internet-based literature search through June 2015 was performed for information related to biosimilar manufacturin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9a67e26fce7a8e86a3840d2413432135
https://pubmed.ncbi.nlm.nih.gov/26947440
https://pubmed.ncbi.nlm.nih.gov/26947440
Publikováno v:
Analytical Chemistry. 74:5799-5806
A novel and practical technique for performing both parent and neutral loss (PNL) monitoring experiments on a quadrupole ion trap mass spectrometer is presented. This technique is capable of performing scans analogous to the parent and neutral loss s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7fef798664268de2eb0a8d48f8895b20
https://doi.org/10.1021/ac026073d
https://doi.org/10.1021/ac026073d
Publikováno v:
Analytical Chemistry. 74:3760-3771
Electrospray ionization-Fourier transform ion cyclotron resonance tandem mass spectrometry is used to study the influence of charge state on the product ion spectra of chondroitin sulfate oligosaccharides for determination of the sulfate position on
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::cfe29eb9f79e49c6469ef886a3d52c9e
https://doi.org/10.1021/ac025506+
https://doi.org/10.1021/ac025506+
Publikováno v:
Analytical Chemistry. 74:402-412
In the quadrupole ion trap, it has been noted that factors other than an ion's mass and charge may affect its measured m/z, resulting in compound-dependent, or "chemical", mass shifts. We propose that ions can exhibit a chemical mass shift because th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b5dbbfe3cdd5609726234a5cce5e0446
https://doi.org/10.1021/ac015610b
https://doi.org/10.1021/ac015610b
Publikováno v:
Analytical Chemistry. 73:6030-6039
Chondroitin sulfate (CS) is a glycosaminoglycan consisting of repeating uronic acid, N-acetylgalactosamine sulfate disaccharide units [-UroA(beta1,3)-GalNAcS(beta1,4)]n. Chondroitin sulfate type A (CSA) contains glucuronic acid, and 90% of the GalNAc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::74a8325258c63b2d8224d59225ccf4f9
https://doi.org/10.1021/ac015577t
https://doi.org/10.1021/ac015577t
Publikováno v:
Rapid Communications in Mass Spectrometry. 11:1961-1970
Electrospray ionization (ESI) tandem mass spectrometry collision-induced dissociation (CID) fragmentation processes of a series of nitroaromatic, nitramine and nitrate ester explosives were studied in the negative-ion mode using daughter-ion, parent-
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e5fd02a181a71817eecafd815887ec11
https://doi.org/10.1002/(sici)1097-0231(199712)11:18<1961::aid-rcm99>3.0.co
https://doi.org/10.1002/(sici)1097-0231(199712)11:18<1961::aid-rcm99>3.0.co