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CONSENSUS AND RECOMMENDATION OF THE L1 GLOBAL HARMONIZATION TEAM ON RUN ACCEPTANCE FOR LARGE MOLECULE BIOANALYSIS TO SUPPORT PHARMACOKINETICS

Kelley, Marian and Beaver, Christopher and Stevenson, Lauren and Bamford, Ross and Gegwich, Paula and Li, Dongbei and Little, Samantha and Muraganandam, Arumugam and Stoellner, Daniela and Trivedi, Ravi Kumar (2014) CONSENSUS AND RECOMMENDATION OF THE L1 GLOBAL HARMONIZATION TEAM ON RUN ACCEPTANCE FOR LARGE MOLECULE BIOANALYSIS TO SUPPORT PHARMACOKINETICS. AAPS Journal, 16 (2). pp. 221-225.

Abstract

The L1 Global Harmonization Team on run acceptance, specifically for large molecule bioanalysis in support of pharmacokinetics, focused on standard curve calibrators and quality controls for use in both validation and study sample analysis, including their preparation and acceptance criteria. The team also considered curve editing and the concept of Total Error.

Item Type: Article
Additional Information: Work done in the L1 Global Harmonization team of the Global Bioanalysis Consortium (GBC)
Keywords: Standard Curve Calibrators; Accuracy and Precision (A&P), Quality Controls; Acceptance Criteria; Curve Editing; Total Error
Date Deposited: 13 Oct 2015 13:13
Last Modified: 13 Oct 2015 13:13
URI: https://oak.novartis.com/id/eprint/10060

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