Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
文献类型：期刊论文
| 作者 | Fluhler, Eric3,4; Vazvaei, Faye2; Singhal, Puran12; Vinck, Petra11; Li, Wenkui10; Bhatt, Jignesh9; de Boer, Theo8; Chaudhary, Ajai7; Tangiuchi, Masahiro5; Rezende, Vinicius1 |
| 刊名 | AAPS JOURNAL
 |
| 出版日期 | 2014-11 |
| 卷号 | 16期号:6页码:1167-1174 |
| 关键词 | harmonization incurred sample reanalysis regulated bioanalysis repeat analysis |
| ISSN号 | 1550-7416 |
| DOI | 10.1208/s12248-014-9644-1 |
| 文献子类 | Review |
| 英文摘要 | The A7 harmonization team (A7 HT), a part of the Global Bioanalysis Consortium (GBC), focused on reviewing best practices for repeat analysis and incurred sample reanalysis (ISR) as applied during regulated bioanalysis. With international representation from Europe, Latin America, North America, and the Asia Pacific region, the team first collated common practices and guidance recommendations and assessed their suitability from both a scientific and logistical perspective. Subsequently, team members developed best practice recommendations and refined them through discussions and presentations with industry experts at scientific meetings. This review summarizes the team findings and best practice recommendations. The few topics where no consensus could be reached are also discussed. The A7 HT recommendations, together with those from the other GBC teams, provide the basis for future international harmonization of regulated bioanalytical practices. |
| WOS关键词 | METHODS VALIDATION |
| WOS研究方向 | Pharmacology & Pharmacy |
| 语种 | 英语 |
| WOS记录号 | WOS:000344345000005 |
| 出版者 | SPRINGER |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/276855]  |
| 专题 | 上海药物代谢研究中心 |
| 通讯作者 | Fluhler, Eric |
| 作者单位 | 1.Univ Sao Paulo, Sch Med, Dept Hematol, Sao Paulo, Brazil; 2.Roche Innovat Ctr New York, Global DMPK & Bioanalyt R&D, Roche Pharma Res & Early Dev, New York, NY USA; 3.Pfizer, PDM NBE, Pearl River, NY 10965 USA; 4.Pfizer R&D, Pearl River, NY 10992 USA 5.SCAS BTT Bioanal Co Ltd, Chungcheongbuk Do, South Korea; 6.Chinese Acad Sci, Shanghai Inst Mat Med, Shanghai 200031, Peoples R China; 7.Merck Res Labs, PPDM, West Point, PA USA; 8.Analyt Biochem Lab BV, AJ, Assen, Netherlands; 9.Torrent Pharmaceut Ltd, Bioevaluat Ctr, Gandhinagar, Gujarat, India; 10.Novartis Inst Biomed Res, East Hanvover, NJ USA; |
| 推荐引用方式 GB/T 7714 | Fluhler, Eric,Vazvaei, Faye,Singhal, Puran,et al. Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team[J]. AAPS JOURNAL,2014,16(6):1167-1174. |
| APA | Fluhler, Eric.,Vazvaei, Faye.,Singhal, Puran.,Vinck, Petra.,Li, Wenkui.,...&Zhong, Dafang.(2014).Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team.AAPS JOURNAL,16(6),1167-1174. |
| MLA | Fluhler, Eric,et al."Repeat Analysis and Incurred Sample Reanalysis: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team".AAPS JOURNAL 16.6(2014):1167-1174. |
入库方式： OAI收割
来源：上海药物研究所
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