Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Elise Burmeister Getz"'
Autor:
Akiko Shimamura, Alexey Maschan, Carolyn Bennett, Jason E Farrar, Sujith Samarasinghe, Brigitte Strahm, Winfred C. Wang, Adrianna Vlachos, Charlotte M. Niemeyer, Timothy S. Olson, Denise D'Alessio, Elise Burmeister Getz, Tomasz Lawniczek, Yunnan Xu, David A. Williams
Publikováno v:
Blood. 140:705-707
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::8a1398af1cad59f95e080e7d594325d4
https://doi.org/10.1182/blood-2022-158214
https://doi.org/10.1182/blood-2022-158214
Autor:
Elise Burmeister Getz, Scott Haughie, Hayden Beresford, Svetlana Lyapustina, Christopher Wiggenhorn, Alessandro Cavecchi, J. David Christopher, Helen Strickland, Kevin J. Carroll, Beth Morgan
Publikováno v:
AAPS PharmSciTech
Batch-to-batch pharmacokinetic (PK) variability of orally inhaled drug products has been documented and can render single-batch PK bioequivalence (BE) studies unreliable; results from one batch may not be consistent with a repeated study using a diff
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7c2f34313abb34c36d09442a1e758ba0
https://doi.org/10.1208/s12249-021-02063-1
https://doi.org/10.1208/s12249-021-02063-1
Publikováno v:
AAPS PharmSciTech. 22
Pharmacokinetic differences between manufacturing batches, well established for inhaled drug products, preclude control of patient risk in the customary two-way (single batch) pharmacokinetic bioequivalence crossover design if batches are randomly ch
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::121486244159b2dd403bfd9cf19a0ef1
https://doi.org/10.1208/s12249-021-02064-0
https://doi.org/10.1208/s12249-021-02064-0
Autor:
Keyur Joshi, Elise Burmeister Getz, David Christopher, Thomas Hoffelder, Marisa Pertile, Svetlana Lyapustina, Monisha Dey, Beth Morgan, Stephen Andrews, Hayden Beresford, David Wilcox, Göran Långström, Helen Strickland, Mark R. Berry, Christopher Wiggenhorn, Stephanie T. Chen, Daniela Acerbi, Mary McKenry
Publikováno v:
AAPS PharmSciTech. 19:1410-1425
This article reports performance characteristics of the population bioequivalence (PBE) statistical test recommended by the US Food and Drug Administration (FDA) for orally inhaled products. A PBE Working Group of the International Pharmaceutical Aer
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b83feda729bc0f0ac163f956604ff769
https://doi.org/10.1208/s12249-017-0941-8
https://doi.org/10.1208/s12249-017-0941-8
Publikováno v:
Clinical Pharmacology & Therapeutics. 105:326-328
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e51e00bc20c6d3da06d7f56c9fd413c
https://doi.org/10.1002/cpt.1294
https://doi.org/10.1002/cpt.1294
Autor:
Beth Morgan, David Christopher, Helen Strickland, Svetlana Lyapustina, Christopher Wiggenhorn, Stephanie T. Chen, Elise Burmeister Getz, Hayden Beresford, Göran Långström
Publikováno v:
AAPS PharmSciTech. 20(7)
This article extends previous work studying performance characteristics of the population bioequivalence (PBE) statistical test recommended by the US Food and Drug Administration (FDA) for orally inhaled and nasal drug products. Based on analysis of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1add8c15dc043cf2fd5c90c6d77aba27
https://pubmed.ncbi.nlm.nih.gov/31444601
https://pubmed.ncbi.nlm.nih.gov/31444601
Publikováno v:
Pharmaceutical Inhalation Aerosol Technology ISBN: 9780429055201
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6f3225723dea2ad9ecdb7e2a56835678
https://doi.org/10.1201/9780429055201-31
https://doi.org/10.1201/9780429055201-31
Publikováno v:
Journal of Clinical Pharmacology
In bioequivalence (BE) testing, it is the convention to identify tlast separately for each concentration‐vs‐time profile. Within‐subject differences in tlast between treatments can arise when assay sensitivity is reached during washout, causing
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c89b95f3150f1e553b15bdebea55cc10
http://europepmc.org/articles/PMC5064724
http://europepmc.org/articles/PMC5064724
Publikováno v:
Annals of the American Thoracic Society. 14(2)
OT329 SOLIS is a generic candidate for the branded asthma treatment, ADVAIR DISKUS (fluticasone propionate/salmeterol xinafoate), and, as such, the manufacturer is required to provide evidence of clinical "bioequivalence" as a condition for regulator
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ae1c2380de6de90dbc97a19897866b7a
https://pubmed.ncbi.nlm.nih.gov/28146386
https://pubmed.ncbi.nlm.nih.gov/28146386
Publikováno v:
The Journal of Clinical Pharmacology. 49:1025-1036
Pitrakinra, a 15-kDa recombinant human interleukin-4 mutein, targets allergic Th2 inflammation by competitively binding to interleukin-4 receptor alpha to interfere with interleukin-4 and interleukin-13 action. The authors characterized pitrakinra ph
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c33aad2cdbe8af89cb471fdc6e38831c
https://doi.org/10.1177/0091270009341183
https://doi.org/10.1177/0091270009341183