Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
| Autor: | Yamamoto Katsuhiko, Daniela Stoellner, Lauren Stevenson, Dongbei Li, Ross Bamford, Arumugam Muruganandam, Christopher Beaver, Marian Kelley, Samantha Little, Paula Gegwich, Ravi Kumar Trivedi |
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| Rok vydání: | 2014 |
| Předmět: |
Quality Control
Bioanalysis Macromolecular Substances Computer science Management science Best practice media_common.quotation_subject White Paper Pharmaceutical Science Sample (statistics) Harmonization Validation Studies as Topic Total error Engineering management Acceptance testing Practice Guidelines as Topic Quality (business) media_common |
| Zdroj: | The AAPS Journal. 16:221-225 |
| ISSN: | 1550-7416 |
| Popis: | The L1 Global Harmonization Team provides recommendations specifically for run acceptance of ligand binding methods used in bioanalysis of macromolecules in support of pharmacokinetics. The team focused on standard curve calibrators and quality controls for use in both pre-study validation and in-study sample analysis, including their preparation and acceptance criteria. The team also considered standard curve editing and the concept of total error. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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