Zobrazeno 1 - 10
of 25
pro vyhledávání: '"Sheila Breidinger"'
Autor:
Marissa F, Dockendorf, David, Jaworowicz, Rebecca, Humphrey, Melanie, Anderson, Sheila, Breidinger, Lei, Ma, Theresa, Taylor, Nicole, Dupre, Christopher, Jones, Christine, Furtek, Bhavna, Kantesaria, Kevin P, Bateman, Eric, Woolf, Michael F, Egan, Julie A, Stone
Publikováno v:
The AAPS Journal. 24
In-clinic venous dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer's disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential alternative to plasma PK sampling. I
Autor:
Li Sun, Yang Xu, Neal Dube, Melanie Anderson, Sheila Breidinger, Pavan Vaddady, Bob Thornton, Linda Morrow, Randolph P. Matthews, S. Aubrey Stoch, Eric J. Woolf
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 212
For pharmacokinetics characterization of a therapeutic insulin dimer, an ultrasensitive plasma method was required due to the expected low circulating levels in humans. A bioanalytical strategy combining immunoprecipitation enrichment with liquid chr
Autor:
Melanie Anderson, Marissa F. Dockendorf, Ian McIntosh, Iris Xie, Sheila Breidinger, Dongfang Meng, Sumei Ren, Wendy Zhong, Li Zhang, Brad Roadcap, Kevin P. Bateman, Julie Stone, Eric Woolf
Publikováno v:
The AAPS journal. 24(3)
In-clinic dried blood spot (DBS) pharmacokinetic (PK) sampling was incorporated into two phase 3 studies of verubecestat for Alzheimer's disease (EPOCH [NCT01739348] and APECS [NCT01953601]), as a potential alternative to plasma PK sampling for impro
Autor:
Kerry L. Fillgrove, Deanne Jackson Rudd, Eric Woolf, Melanie Anderson, Rena Zhang, Bing Lu, Suzie Yeh, Cynthia Chavez-Eng, Sheila Breidinger, Li Sun, Iris Xie
Publikováno v:
Bioanalysis. 11:233-250
Aim: MK-8591 (EFdA), a novel anti-HIV nucleoside analog, is converted to mono-, di- and tri-phosphates (MK-8591-MP, MK-8591-DP and MK-8591-TP) intracellularly, among which MK-8591-TP is the active pharmacological form. An ultrasensitive LC–MS/MS as
Autor:
Helengrace Schuck, Sheila Breidinger, Kenneth Willson, Yang Xu, Eric Woolf, Tonya Jackson, Dina Goykhman, Jane Harrelson, Ming Wang, Iris Xie
Publikováno v:
Bioanalysis. 10:1207-1220
Aim: Advances in technology have led to a shift for peptide quantification from traditional ligand-binding assays to LC–MS/MS-based analysis, which presents challenges, in other assay sensitivity, specificity and ruggedness, in addition to lacking
Autor:
Lingling Xue, Sheila Breidinger, Kevin P. Bateman, Eric Woolf, Melanie Anderson, Dina Goykhman, Ming Wang, Iris Xie, Yang Xu
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 156:58-66
Volumetric absorptive microsampling (VAMS), a new microsampling technique, was evaluated for its potential in supporting regulated bioanalysis. Our initial assessment with MK-0518 (raltegravir) using a direct extraction method resulted in 45-52% extr
Autor:
Eric Woolf, Melanie Anderson, Marie-Josée Marcoux, Li Sun, Philippe Bélanger, Vincent Trinh, Sheila Breidinger, Bhavna Kantesaria, Yang Xu, Dina Goykhman, Kevin P. Bateman, Patricia Lavallée
Publikováno v:
Journal of Chromatography B. 1063:50-59
MK-1293 is a newly approved follow-on/biosimilar insulin glargine for the treatment of Type 1 and Type 2 diabetics. To support pivotal clinical studies during biosimilar evaluation, a sensitive, specific and robust liquid chromatography and tandem ma
Publikováno v:
Bioanalysis. 8:2183-2187
17th Annual Land O'Lakes Bioanalytical Conference, Madison, WI, USA, 11–14 July 2016 The 17th Annual Land O'Lakes Bioanalytical Conference, titled ‘Biomarker Validation, Stability, and Regulatory Concerns’, was held on 11–14 July 2016 (Monday
Autor:
Sheila Breidinger, Eric Woolf
Publikováno v:
Regulated Bioanalysis: Fundamentals and Practice ISBN: 9783319548005
The history and key concepts of bioanalysis are discussed. Historically, the scientific need driving the development of bioanalytical methodology was the evolution of the science of pharmacology as well as the field of pharmacokinetics. Similarly, th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d7cae64aebbe23c3f15bc007db3c0e0e
https://doi.org/10.1007/978-3-319-54802-9_5
https://doi.org/10.1007/978-3-319-54802-9_5
Autor:
Narayana I. Narasimhan, John A. Wagner, Nancy G. B. Agrawal, Jacqueline B. McCrea, John Palcza, Kyriakos P. Papadopoulos, Anthony W. Tolcher, Sheila Breidinger, Mark Stroh, Deborah Panebianco, Jennifer Talaty, Amita Patnaik, Michele Trucksis, Richard Lush, Keith Orford, Punam Sandhu
Publikováno v:
The Journal of Clinical Pharmacology. 54:1256-1262
Ridaforolimus, a unique non-prodrug analog of rapamycin, is a potent inhibitor of mTOR under development for cancer treatment. In vitro data suggest ridaforolimus is a reversible and time-dependent inhibitor of CYP3A. A model-based evaluation suggest