Zobrazeno 1 - 6
of 6
pro vyhledávání: '"Dominador Calamba"'
Publikováno v:
Pharmaceutical Research
Purpose To investigate the mechanisms of clearance of AMG 386, an investigational recombinant peptide-Fc fusion protein (peptibody) that blocks tumor angiogenesis by neutralizing the interaction between angiopoietin-1 and -2 and the Tie2 receptor. Me
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eb63f6d41fd3516a611762a1a308e35c
https://doi.org/10.1007/s11095-011-0650-z
https://doi.org/10.1007/s11095-011-0650-z
Autor:
Michael Eschenberg, Binodh DeSilva, Theingi M. Thway, Mark Ma, Dominador Calamba, Chris Macaraeg
Publikováno v:
The AAPS Journal. 13:291-298
Incurred sample reanalysis (ISR) is recommended by regulatory agencies to demonstrate reproducibility of validated methods and provide confidence that methods used in pharmacokinetic and toxicokinetic assessments give reproducible results. For macrom
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::54ab8a32d379a82a4c6954cef10ed544
https://doi.org/10.1208/s12248-011-9271-z
https://doi.org/10.1208/s12248-011-9271-z
Autor:
Laura Brunner, Liana Zhang, Ramak Pourvasei, Mark Ma, Theingi M. Thway, Chris Macaraeg, Michael Eschenberg, Binodh DeSilva, Dominador Calamba
Publikováno v:
Bioanalysis. 2:1587-1596
Background: Incurred sample reanalysis (ISR) is the most recent in-study validation parameter that regulatory agencies have mandated to ensure reproducibility of bioanalytical methods supporting pharmacokinetic/toxicokinetic and clinical studies. The
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c3cc0f1f8912df3d7b99cd5ee503db33
https://doi.org/10.4155/bio.10.75
https://doi.org/10.4155/bio.10.75
Autor:
Vimal Patel, Dominador Calamba, Binodh DeSilva, Chris Macaraeg, Jean W. Lee, Mark Ma, Theingi M. Thway, Jennifer Tsoi
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 51:626-632
Development and validation of ligand binding methods that can measure therapeutic antibodies (TA) accurately and precisely are essential for bioanalysis that supports regulated pharmacokinetic (PK) and toxicokinetic (TK) studies. Non-bead (planar) el
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::74604366cc9c7b9abbfd1c444038059f
https://doi.org/10.1016/j.jpba.2009.09.035
https://doi.org/10.1016/j.jpba.2009.09.035
Decisions about efficacy and safety of therapeutic proteins (TP) designed to target soluble ligands are made in part by their ex vivo quantification. Ligand binding assays (LBAs) are critical tools in measuring serum TP levels in pharmacokinetic, tox
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e30769d963d1ad8a2968983c00f10bbc
https://europepmc.org/articles/PMC4627453/
https://europepmc.org/articles/PMC4627453/
Publikováno v:
Bioanalysis. 7(11)
Chris Macaraeg has been a lead scientist for method development, validation, and study support intended for regulated pre-clinical/clinical studies within the Pharmacokinetics and Drug Metabolism department at Amgen Inc, Thousand Oaks, CA. He joined
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2fa93c2c772c77987d489e418b3a74b7
https://pubmed.ncbi.nlm.nih.gov/26110709
https://pubmed.ncbi.nlm.nih.gov/26110709