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