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 70
- Downloads 0
No evidence for the involvement of the multidrug resistance-associated protein and/or the monocarboxylic acid transporter in the intestinal transport of fluvastatin in rats
Fluvastatin, an amphiphilic anion, shows a nonlinear increase in effective intestinal permeability (Peff) with increasing lumenal concentrations in rats. The main objective of this study was to investigate whether or not...
Development of a Complex Parent-Metabolite Joint Population Pharmacokinetic Model
This study aimed to develop a joint population pharmacokinetic model for an antipsychotic agent in development ({"type":"entrez-protein","attrs":{"text":"S33138","term_id":"423514","term_text":"pir||S33138"}} S33138) and...
A Novel Ultrasensitive Hybridization-Based ELISA Method for 2-Methoxyphosphorothiolate MicroRNAs and Its In vitro and In vivo Application
MicroRNAs (miRNAs) are endogenous, small non-coding RNAs that bind to target mRNAs and regulate their expression. Recent evidence has indicated the involvement of miRNAs in human malignancies. It has been suggested that...
In vitro evaluation of chitosan-EDTA conjugate polyplexes as a nanoparticulate gene delivery system
It was the purpose of this study to evaluate the potential of different molecular-weight chitosan-EDTA conjugates as a carrier matrix for nanoparticulate gene delivery systems. Covalent binding of EDTA to more than one c...
Strategy to Prevent Drug-Related Hypersensitivity in Folate-Targeted Hapten Immunotherapy of Cancer
Cancer vaccine/immunotherapy rarely involves systemic administration of an immunogenic compound to an actively immunized host. We have developed such a strategy that utilizes folate to deliver antigenic haptens [e.g., fl...