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Recommendations on Incurred Sample Stability (ISS) by GCC

2014; Future Science Ltd; Volume: 6; Issue: 18 Linguagem: Inglês

10.4155/bio.14.155

1757-6199

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

Statistical Methods in Clinical Trials

The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the seventh annual Workshop on Recent Issues in Bioanalysis (WRIB) held in Long Beach, CA, USA, in April 2013, and at the Global CRO Council for Bioanalysis (GCC) meeting preceding it. Discussion at both events focused on the use of incurred samples for ISS purposes in light of results from a recent GCC survey completed by member companies. This paper reports the consensus resulting from these discussions and serves as a useful reference for depicting ISS issues and concerns, summarizing the GCC survey results and providing helpful recommendations on ISS in the context of bioanalytical method development and application.