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
Related Articles
- EP ID EP681072
- DOI 10.1208/s12248-013-9556-5
- Views 47
- Downloads 0
Preparation, characterization, and biodistribution study of technetium-99m-labeled leuprolide acetate-loaded liposomes in ehrlich ascites tumor-bearing mice
The purpose of this study was to prepare conventional and sterically stabilized liposomes containing leuprolide acetate in an attempt to prolong the biological half life of the drug, to reduce the uptake by reticuloendot...
Predictive Models of Diffusive Nanoparticle Transport in 3-Dimensional Tumor Cell Spheroids
The rapidly evolving nanotechnology field highlights the need of better understanding the relationship between nanoparticle (NP) properties and NP transport in solid tumors. The present study tested the hypothesis that t...
Statistical Comparison of Dissolution Profiles to Predict the Bioequivalence of Extended Release Formulations
The online version of this article (doi:10.1208/s12248-014-9615-6) contains supplementary material, which is available to authorized users.
Mathematical modeling of surface-active and non-surface-active drug transport in emulsion systems
Mathematical models were developed for the prediction of surface-active and non- surface-active drug transport in triphasic (oil, water, and micellar) emulsion systems as a function of micellar concentration. These model...
Optimizing targeted gene delivery: Chemical modification of viral vectors and synthesis of artificial virus vector systems
In comparison to classical medicines, gene therapy has the potential to mediate the highest possible level of therapeutic specificity. Every normal or diseased cell can switch on or off a gene expression cassette in a ti...