The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud
| العنوان: | The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud |
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| المؤلفون: | Andrea Wakefield, Barry van der Strate, Elizabeth Groeber, Saadya Fatmi, Jing Tu, John Allinson, Yansheng Liu, Hanna Ritzén, John Kamerud, Maria Cruz Caturla, Phyllis Conliffe, Zhongping John Lin, Rafiq Islam, Kayode Awaiye, Chad Briscoe, Jenny Lin, Javier Torres, James Hulse, Jim Yamashita, Shane Karnik, Anahita Keyhani, Simona Rizea Savu, Yinghe Li, Nicola Hughes, Rabab Tayyem, Patrick Bennett, Mike Buonarati, Laura Cojocaru, Wei Garofolo, Steve Lowes, Prashant Kale, Afshin Safavi, Dominic Warrino, Mohammed Bouhajib, Paul Rhyne, Michele Malone, Stephanie Mowery, Bruce Stouffer, Mathilde Yu, Daniel Tang, Masood Khan, Ira DuBey, Neil Adcock, Nadine Boudreau, Radha Shekar, Ardeshir Khadang, Edward O'Connor, Christina Satterwhite, Edward Tabler, Philippe Couerbe, Ron Shoup, Adriana Iordachescu, Jennifer Zimmer, Eric Thomas, Natasha Savoie, Jenifer Vija, Rhonda Johnson, Stephanie Cape, Clark V. Williard, Christina Sanchez, Kai Kurylak, Chris Beaver, Corey Nehls, James Bourdage, Mohamed Osman, Brent Matthews, Roger Hayes, Luigi Silvestro, Michele Fiscella |
| المصدر: | Bioanalysis. 9:505-516 |
| بيانات النشر: | Future Science Ltd, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Research Report, Bioanalysis, Computer science, Clinical Biochemistry, Stability (learning theory), Guidelines as Topic, Sample (statistics), Bioinformatics, 030226 pharmacology & pharmacy, 01 natural sciences, Chemistry Techniques, Analytical, Analytical Chemistry, 03 medical and health sciences, 0302 clinical medicine, Drug Stability, Acceptance testing, Data integrity, Humans, General Pharmacology, Toxicology and Pharmaceutics, Notice, Data Collection, Matrix stability, 010401 analytical chemistry, General Medicine, Sample stability, 0104 chemical sciences, Medical Laboratory Technology, Engineering management, Pharmaceutical Preparations, Government Regulation, Biomarkers |
| الوصف: | The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO–Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report. |
| تدمد: | 1757-6199 1757-6180 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1dd221211c9c17d74f26ad79eddd99f3 https://doi.org/10.4155/bio-2017-5000 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....1dd221211c9c17d74f26ad79eddd99f3 |
| قاعدة البيانات: | OpenAIRE |
PDF full text from Publisher | تدمد: | 17576199 17576180 |
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