Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Chantal DiMarco"'
GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline
Autor:
Xinping Fang, Cheikh Kane, Valentine Barra, Dawn Dufield, Marsha Luna, Adriane Spytko, Jerome Bergeron, Corey Nehls, Robert MacNeill, Andrew Dinan, Esme Farley, Scott Reuschel, Hao Wang, Chantal DiMarco, Timothy Sangster, John Stamatopoulos, Shane Karnik, Nadine Boudreau, Kathie Lindley, Sarah Maasjo, Ariana Tudoroniu, Changming Yang, Jennifer Vance, Christina Satterwhite, Hao Feng, Ira DuBey, Jing Shi, Natasha Savoie, Brian K. Hoffpauir, Kurt J. Sales, Travis Harrison, Orlando Bravo, Jenifer Vija, Jason Ambrosius, Ardeshir Khadang, Chad Briscoe, Stephanie Cape, Edward Tabler, Philippe Couerbe, Adriana Iordachescu, Evgueni Fedorov, Jennifer Zimmer, Roger Hayes, Luca Matassa, Michael H. Buonarati, Franklin Spriggs, Stacie McCown, Michael E. Brown, Wei Garofolo, Jenny Lin, John Lindsay, Paul Rhyne, Shelby Anderson, Bruce Stouffer, Rafiq Islam, John Pirro, Edward Wells, Angie Underberg, Saadya Fatmi, Philip Joyce, Shaolian Zhou, Mohammed Bouhajib, Joseph Bower, Hanna Ritzén, Liam Moran
Publikováno v:
Bioanalysis. 11(18s)
The 13th GCC Closed Forum for Bioanalysis was held in New Orleans, Louisiana, USA on April 5th, 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in February 201
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4f70e570638ab396bb6fddadea18efb8
https://pubmed.ncbi.nlm.nih.gov/31565956
https://pubmed.ncbi.nlm.nih.gov/31565956
Autor:
Mathilde Yu, Michele Malone, John Stamatopoulos, Christina Satterwhite, George Hristopoulos, Simona Rizea Savu, Mohammed Bouhajib, Chad Briscoe, Edward Tabler, Philippe Couerbe, Edward Wells, Ardeshir Khadang, Ira DuBey, Sian Estdale, Mark Warren, Hanna Ritzén, Wei Garofolo, Franklin Spriggs, Arron Xu, Chris Beaver, Jennifer Zimmer, Iohann Boulay, Anahita Keyhani, Kayode Awaiye, Vellalore Kakkanaiah, Curtis Sheldon, Jessica St Charles, Roger Hayes, Patrick Bennett, James Bourdage, Yi Qun Xiao, Marc Moussallie, Sumit Kar, Shane Karnik, Rabab Tayyem, Maria Cruz Caturla, Clark V. Williard, Hao Wang, Nadia Kulagina, Nicola Hughes, Robert MacNeill, Luigi DiMarco, Andrew Dinan, Kathie Lindley, Natasha Savoie, Xinping Fang, Chantal DiMarco, Bruce Stouffer, Jenifer Vija, Corey Nehls, Stephanie Cape, Eric Thomas, John Lindsay, Paul Rhyne, Michael E. Brown, Jenny Lin, Amanda Hays, Allan Xu, Hao Feng, Lawrence Goodwin, Rafiq Islam, Colin Barry, Dave Williams
Publikováno v:
Bioanalysis. 11(7)
Over the last decade, the use of biomarker data has become integral to drug development. Biomarkers are not only utilized for internal decision-making by sponsors; they are increasingly utilized to make critical decisions for drug safety and efficacy
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::34219e762535ddd3b0da39d50cd5b1ec
https://pubmed.ncbi.nlm.nih.gov/30993999
https://pubmed.ncbi.nlm.nih.gov/30993999
Autor:
Isabelle Dumont, Paul Rhyne, Saadya Fatmi, Curtis Sheldon, Rafiq Islam, Yanseng Liu, Roger Hayes, Dick Tacey, William Nowatzke, Gene Ray, Jenny Lin, Jennifer Bravo, Gary Schultz, Robert Nicholson, Barry van der Strate, Jim Datin, Chad Briscoe, Elizabeth Groeber, Teri Pekol, Tim Lansing, Jordi Ortuno, Rand Jenkins, Ira DuBey, Andrew Roberts, Mike Buonarati, Andrea Watson, Douglas M. Fast, John Lin, John Kamerud, Mathilde Yu, Daniel Tang, Michele Malone, Laura Cojocaru, Allan Xu, Petra Struwe, Masood Khan, Ann Levesque, Richard LeLacheur, Kai Kurylak, Colin Farrell, Steve Lowes, Mohammed Bouhajib, Ronald Shoup, John Doughty, Joseph Bower, Gibran El-Sulayman, Chantal DiMarco, Alexandre Blanchette, Mary Carbone, Phyllis Conliffe, Fabio Garofolo, Dominique Gouty, Jim Hulse, Jamil Hantash, Jennifer Zimmer, Mike Redrup, Scott Reuschel, Sofi Gagnon-Carignan, Maria Cruz Caturla, Mike Allen, Wei Garofolo, Xinping Fang, Shane Karnik
Publikováno v:
Bioanalysis. 6:2957-2963
The 8th GCC Closed Forum for Bioanalysis was held in Baltimore, MD, USA on 5 December 2013, immediately following the 2013 AAPS Workshop (Crystal City V): Quantitative Bioanalytical Methods Validation and Implementation – The 2013 Revised FDA Guida
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::f65897a65520e2ae7e6f583b208f47fb
https://doi.org/10.4155/bio.14.287
https://doi.org/10.4155/bio.14.287