title: Recommendations from the Global Bioanalysis Consortium Team A8: documentation.
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.affiliation: Janssen Research and Development, Turnhoutseweg 30, 2340, Beerse, Belgium, tverhaeg@its.jnj.com.
authors.forename: Tom
authors.initials: T
authors.lastname: Verhaeghe
authors.forename: Hollie H
authors.initials: HH
authors.lastname: Barton
authors.forename: Hisanori
authors.initials: H
authors.lastname: Hara
authors.forename: Richard
authors.initials: R
authors.lastname: Hucker
authors.forename: Marian
authors.initials: M
authors.lastname: Kelley
authors.forename: Franck
authors.initials: F
authors.lastname: Picard
authors.forename: K Srinivasa
authors.initials: KS
authors.lastname: Reddy
authors.forename: Myriam Clara
authors.initials: MC
authors.lastname: Salvadori
authors.forename: Eric
authors.initials: E
authors.lastname: Woolf
mesh_terms: D001681:Biological Assay / Q000592:standards*; D002138:Calibration; D004282:Documentation; D007391:International Cooperation; D054928:Validation Studies as Topic