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8th GCC: consolidated feedback to US FDA on the 2013 draft FDA guidance on bioanalytical method validation.
Bower, Joseph; Fast, Douglas; Garofolo, Fabio; Gouty, Dominique; Hayes, Roger; Lowes, Steve; Nicholson, Robert; LeLacheur, Richard; Bravo, Jennifer; Shoup, Ronald; Dumont, Isabelle; Carbone, Mary; Zimmer, Jennifer; Ortuno, Jordi; Caturla, Maria Cruz; Datin, Jim; Lansing, Tim; Fatmi, Saadya; Struwe, Petra; Sheldon, Curtis; Islam, Rafiqul; Yu, Mathilde; Hulse, Jim; Kamerud, John; Lin, John; Doughty, John; Kurylak, Kai; Tang, Daniel; Buonarati, Mike; Blanchette, Alexandre; Levesque, Ann; Gagnon-Carignan, Sofi; Lin, Jenny; Ray, Gene; Liu, Yanseng; Khan, Masood; Xu, Allan; El-Sulayman, Gibran; DiMarco, Chantal; Bouhajib, Mohammed; Tacey, Dick; Jenkins, Rand; der Strate, Barry van; Briscoe, Chad; Karnik, Shane; Rhyne, Paul; Garofolo, Wei; Schultz, Gary; Roberts, Andrew; Redrup, Mike.
Affiliation
  • Bower J; Covance Laboratories, Chantilly, VA, USA.
Bioanalysis ; 6(22): 2957-63, 2014.
Article in En | MEDLINE | ID: mdl-25496252
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Full text: 1 Database: MEDLINE Main subject: Chemistry Techniques, Analytical / Guidelines as Topic / Validation Studies as Topic Type of study: Guideline Country/Region as subject: America do norte Language: En Year: 2014 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Chemistry Techniques, Analytical / Guidelines as Topic / Validation Studies as Topic Type of study: Guideline Country/Region as subject: America do norte Language: En Year: 2014 Type: Article