Integrity and efficiency: AbbVie’s journey of building an integrated nonregulated bioanalytical laboratory
| العنوان: | Integrity and efficiency: AbbVie’s journey of building an integrated nonregulated bioanalytical laboratory |
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| المؤلفون: | Yue-Ting Wang, Estelle M Maes, Lance Heinle, Kenneth Ruterbories, Stella Doktor, Mary Larsen, Amanda Olson, Andrew Lee, Cecilia Van Handel, Qin C Ji, Kelly Desino, Gary J Jenkins |
| المصدر: | Bioanalysis. 15:161-176 |
| بيانات النشر: | Future Science Ltd, 2023. |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Medical Laboratory Technology, Clinical Biochemistry, General Medicine, General Pharmacology, Toxicology and Pharmaceutics, Analytical Chemistry |
| الوصف: | While bioanalytical outsourcing is widely adopted in the pharmaceutical industry, AbbVie is one of the few large biopharmaceutical companies having an internal bioanalytical unit to support nearly all its drug metabolism and pharmacokinetic studies. This article highlights our experience and perspective in building an integrated and centralized laboratory to provide early discovery and preclinical-stage bioanalytical support with high operational efficiency, cost–effectiveness and data integrity. The advantages of in-house nonregulated bioanalytical support include better control of data quality, faster turnaround times, real-time knowledge sharing and troubleshooting, and lower near- and long-term costs. The success of an in-house model depends upon a comprehensively optimized and streamlined workflow, fueled by continuous improvements and implementation of innovative technologies. |
| تدمد: | 1757-6199 1757-6180 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::3cc1920e916d06bb8a99047c4a10df06 https://doi.org/10.4155/bio-2023-0012 |
| رقم الأكسشن: | edsair.doi...........3cc1920e916d06bb8a99047c4a10df06 |
| قاعدة البيانات: | OpenAIRE |
PDF full text from Publisher | تدمد: | 17576199 17576180 |
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