Recommendations from the Global Bioanalysis Consortium Team A8: Documentation
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 2
Abstract
The A8 Global Harmonization Team focused on the documentation needed to support both small and large molecule bioanalysis. Current regulatory requirements were compiled and compared. The scope of the team’s discussions included the validation report, the bioanalytical report, study plans, raw data, and bioanalytical summaries for the common technical document (CTD). A common high-level table of contents for method validation and sample analysis reports is proposed. Suggestions have been made as to how the CTD can be standardized to improve usability and review. Additional comments have been made on reports of failure investigations, study plans, and raw data documentation. The recommendation is that no prescriptive guidelines are required in these areas but should be led by good scientific practices subject to particular circumstances.
Authors and Affiliations
Tom Verhaeghe, Hollie H. Barton, Hisanori Hara, Richard Hucker, Marian Kelley, Franck Picard, K. Srinivasa Reddy, Myriam Clara Salvadori, Eric Woolf
Keywords
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- EP ID EP681072
- DOI 10.1208/s12248-013-9556-5
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