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Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Lowes, Steve; Boterman, Mark; Doig, Mira; Breda, Massimo; Jersey, Jim; Lelacheur, Richard; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Zimmer, Jennifer; Caturla, Maria Cruz; Couerbe, Philippe; Maltas, John; Steffen, Ray; Petrilla, James; Safavi, Afshin; Awaiye, Kayode; Bhatti, Masood; Sheldon, Curtis; Schiebl, Christine; Struwe, Petra; Turk, Douglas; Sangster, Timothy; Pattison, Colin; Fast, Douglas; Goodwin, Lee; Kamerud, John; Dinan, Andrew; Mamelak, Dan; Islam, Rafiq; Segers, Rudi; Lin, Zhongping John; Hillier, Jim; Garofolo, Wei; Folguera, Lois; Zimmer, Dieter; Zimmermann, Thomas; Pawula, Maria; Moussallie, Marc; de Souza Teixeira, Leonardo; Rocha, Thais; Allinson, John; Jardieu, Paula; Tang, Daniel; Gouty, Dominique; Wright, Laura; Truog, James; Lin, Jenny.

Bioanalysis ; 4(17): 2117-26, 2012 Sep.

Article in English | MEDLINE | ID: mdl-23013394

ABSTRACT

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.

Subject(s)

Drug Combinations , Pharmaceutical Preparations/analysis , Technology, Pharmaceutical/standards , Biomarkers/analysis , Chromatography, High Pressure Liquid/methods , Drug Stability , Government Regulation , Guidelines as Topic , Humans , Tandem Mass Spectrometry/methods

Recommendations on ISR in multi analyte assays, QA/bioanalytical consultants and GCP by Global CRO Council for Bioanalysis (GCC).

Sangster, Timothy; Maltas, John; Struwe, Petra; Hillier, Jim; Boterman, Mark; Doig, Mira; Breda, Massimo; Garofolo, Fabio; Caturla, Maria Cruz; Couerbe, Philippe; Schiebl, Christine; Pattison, Colin; Goodwin, Lee; Segers, Rudi; Garofolo, Wei; Folguera, Lois; Zimmer, Dieter; Zimmerman, Thomas; Pawula, Maria; Tang, Daniel; Cox, Chris; Bigogno, Chiara; Schoutsen, Dick; de Boer, Theo; Green, Rachel; Houghton, Richard; Sable, Romuald; Siethoff, Christoff; Harter, Tammy; Best, Stuart.

Bioanalysis ; 4(14): 1723-30, 2012 Jul.

Article in English | MEDLINE | ID: mdl-22877218

Subject(s)

Biomarkers/analysis , Chemistry Techniques, Analytical/standards , Pharmaceutical Preparations/analysis , Calibration , Chemistry Techniques, Analytical/methods , Drug Discovery/education , Europe , Humans , Pharmaceutical Preparations/standards , Quality Control , Reference Standards , Reproducibility of Results , Societies, Scientific , Validation Studies as Topic , Workforce

Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC).

Boterman, Mark; Doig, Mira; Breda, Massimo; Lowes, Steve; Jersey, Jim; Shoup, Ronald; Garofolo, Fabio; Dumont, Isabelle; Martinez, Suzanne; Needham, Shane; Cruz Caturla, Maria; Couerbe, Philippe; Guittard, Joelle; Maltas, John; Lansing, Tim; Bhatti, Masood; Schiebl, Christine; Struwe, Petra; Sheldon, Curtis; Hayes, Roger; Sangster, Timothy; Pattison, Colin; Bouchard, Johanne; Goodwin, Lee; Islam, Rafiq; Segers, Rudi; Lin, Zhongping John; Hillier, Jim; Garofolo, Wei; Zimmer, Dieter; Folguera, Lois; Zimmermann, Thomas; Pawula, Maria; Moussallie, Marc; Teixeira, Leonardo de Souza; Rocha, Thais; Tang, Daniel; Jardieu, Paula; Truog, James; Lin, Jenny; Lundberg, Richard; Cox, Chris; Breau, Alan; Bigogno, Chiara; Schoutsen, Dick; Dilger, Carmen; Bouhajib, Mohammed; Levesque, Ann; Gagnon-Carignan, Sofi; Nicholson, Robert.

Bioanalysis ; 4(6): 651-60, 2012 Mar.

Article in English | MEDLINE | ID: mdl-22452256

Subject(s)

Biological Assay/standards , Guidelines as Topic , Pharmaceutical Preparations/analysis , Calibration , Drug Stability , Government Regulation , Humans , Pharmaceutical Preparations/standards , Quality Control , Reference Standards

ABSTRACT

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