title: Tiered approaches to chromatographic bioanalytical method performance evaluation: recommendation for best practices and harmonization from the Global Bioanalysis Consortium harmonization team.
abstract: The A2 harmonization team, a part of the Global Bioanalysis Consortium (GBC), focused on defining possible tiers of chromatographic-based bioanalytical method performance. The need for developing bioanalytical methods suitable for the intended use is not a new proposal and is already referenced in regulatory guidance language. However, the practical implementation of approaches that differ from the well-established full validation requirements has proven challenging. Advances in technologies, the need to progress drug development more efficiently, and emerging new drug compound classes support the use of categorized tiers of bioanalytical methods. This paper incorporated the input from an international team of experienced bioanalysts to surmise the advantages and the challenges of tiered approaches and to provide recommendations on paths forward.
authors.affiliation: Bioanalytical and ADME Labs, Quintiles, 19 Brown Road, Ithaca, New York, 14850, USA, stevelowes@ymail.com.
authors.forename: S
authors.initials: S
authors.lastname: Lowes
authors.forename: R
authors.initials: R
authors.lastname: Hucker
authors.forename: M
authors.initials: M
authors.lastname: Jemal
authors.forename: J C
authors.initials: JC
authors.lastname: Marini
authors.forename: V M
authors.initials: VM
authors.lastname: Rezende
authors.forename: R
authors.initials: R
authors.lastname: Shoup
authors.forename: P
authors.initials: P
authors.lastname: Singhal
authors.forename: P
authors.initials: P
authors.lastname: Timmerman
authors.forename: T
authors.initials: T
authors.lastname: Yoneyama
authors.forename: N
authors.initials: N
authors.lastname: Weng
authors.forename: D
authors.initials: D
authors.lastname: Zimmer
mesh_terms: D002845:Chromatography / Q000379:methods*; D015195:Drug Design; D006801:Humans; D007391:International Cooperation; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013678:Technology, Pharmaceutical / Q000379:methods; D054928:Validation Studies as Topic
chemical_list: D004364:Pharmaceutical Preparations