Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis

Autor: Stacie McCown, Dave Williams, Esme Farley, Jennifer Zimmer, Mark O'Dell, Roger Hayes, Joseph Bower, Ashley Brant, Colin Barry, Todd Lester, Shane Karnik, Elizabeth Groeber, Wei Garofolo, Jennifer Vance, Edward Tabler, Amanda Hays, Dawn Dufield, Marsha Luna, Mitesh Sanghvi, Kurt J. Sales, Rachel Sun, Kelly Dong, Jenny Lin, Anahita Keyhani, Xinping Fang, Orlando Bravo, Natasha Savoie, Steve Lowes, Daksha Desai-Krieger, Allan Xu, Chris Beaver, Cheikh Kane, Sumit Kar, Heidi Renfrew, Christina Satterwhite, Brian K. Hoffpauir, Fabio Garofolo, Sarah Simchik, Stephanie Cape, Rafiq Islam

Publikováno v: Bioanalysis. 13(8)

The 13th Global CRO Council (GCC) closed forum for bioanalysis was held in New Orleans, LA, USA on 5 April 2019. This GCC meeting was organized to discuss the contents of the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline published in F

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d19d5fd9051d2b19e757ff72eb64a8a6
https://pubmed.ncbi.nlm.nih.gov/33847160

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

11th GCC Closed Forum: cumulative stability; matrix stability; immunogenicity assays; laboratory manuals; biosimilars; chiral methods; hybrid LBA/LCMS assays; fit-for-purpose validation; China Food and Drug Administration bioanalytical method validation

Autor: Franklin Spriggs, Chris Beaver, Ashley Brant, Daniel Sikkema, Susan Ohorodnik, John Lindsay, Wei Garofolo, Mike Buonarati, Jing Tu, Chad Briscoe, Scott Fountain, James Hulse, Andrew Dinan, Mark E. Arnold, Rafiq Islam, Saadya Fatmi, James Bourdage, Michael E. Brown, Jim Wilfahrt, Edward Tabler, Philippe Couerbe, Anahita Keyhani, Roger Hayes, Ariana Tudoroniu, Adriana Iordachescu, Kelly Colletti, Jennifer Zemo, Natasha Savoie, Jessica St Charles, John Stamatopoulos, Damon Papac, Colin Barry, Vimal Patel, Gene Ray, Bruce Stouffer, John Marcelletti, Jenny Lin, Jennifer Zimmer, Mark Warren, Mathilde Yu, Maria Cruz Caturla, Philip Joyce, Jenifer Vija, Christina Sanchez, Rachel Green, Xinping Fang, Clark V. Williard, Yansheng Liu, Mohammed Bouhajib, Stephanie Cape, Ira DuBey, Masood Khan, George Hristopoulos, Nicola Hughes, Nadine Boudreau, Barry van der Strate, Rabab Tayyem, Jim Datin, Michael Kennedy, Joanne Hayward-Sewell, Edward Wells, Joseph Bower, Christina Satterwhite, Yi Qun Xiao, Jim Yamashita, Corey Nehls, Curtis Sheldon, Dominic Warrino, Allan Xu, Shane Karnik, Ardeshir Khadang

Publikováno v: Bioanalysis. 10(7)

The 11th Global CRO Council Closed Forum was held in Universal City, CA, USA on 3 April 2017. Representatives from international CRO members offering bioanalytical services were in attendance in order to discuss scientific and regulatory issues speci

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbf30d52d324aed76d79809c62501fab
https://pubmed.ncbi.nlm.nih.gov/29701066

8th GCC: Consolidated feedback to US FDA on the 2013 Draft FDA Guidance on Bioanalytical Method Validation

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

7th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing

Autor: Nadine Boudreau, Saadya Fatmi, Richard LeLacheur, Raymond Farmen, John Allinson, Mohammed Bouhajib, Tianyi Zhang, Mike Buonarati, Ronald Shoup, Mary Stipancic, Brigitte Pellerin, Philippe Couerbe, Joseph Bower, Stephanie Cape, Michelle Fiscella, Marc Moussallie, Jim Hulse, Robert Ian Nicholson, Stephanie Pasas-Farmer, Ian E. Smith, Jennifer Zimmer, Mark Warren, Andrea Watson, John Kamerud, Douglas M. Fast, Allan Xu, Laura Cojocaru, Scott Reuschel, Isabelle Dumont, Jenny Lin, Dominique Gouty, Mario Rocci, Fabio Garofolo, Steve Lowes, Curtis Sheldon, Richard Houghton, Craig Stovold, Xinping Fang, Kayode Awaiye, Roger Hayes, Shane Karnik, Corey Nehls, John Marcelletti, Maria Cruz Caturla, Wei Garofolo

Publikováno v: Bioanalysis. 6(20)

The Global CRO Council for Bioanalysis (GCC), a global independent consortium bringing together many senior level CRO representatives, was created in 2010 in order to openly discuss and share opinions on scientific and regulatory issues specific to t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e583bb62094748f18cd5bda69a864242
https://pubmed.ncbi.nlm.nih.gov/25413703