title: Bioanalysis for plasma protein binding studies in drug discovery and drug development: views and recommendations of the European Bioanalysis Forum.
abstract: Plasma protein binding (PPB) is an important parameter for a drug's efficacy and safety that needs to be investigated during each drug-development program. Even though regulatory guidance exists to study the extent of PPB before initiating clinical studies, there are no detailed instructions on how to perform and validate such studies. To explore how PPB studies involving bioanalysis are currently executed in the industry, the European Bioanalysis Forum (EBF) has conducted three surveys among their member companies: PPB studies in drug discovery (Part I); in vitro PPB studies in drug development (Part II); and in vivo PPB studies in drug development. This paper reflects the outcome of the three surveys, which, together with the team discussions, formed the basis of the EBF recommendation. The EBF recommends a tiered approach to the design of PPB studies and the bioanalysis of PPB samples: 'PPB screening' experiments in (early) drug discovery versus qualified/validated procedures in drug development.
authors.affiliation: TNO Triskelion BV, Utrechtseweg 48, 3704 HE Zeist, The Netherlands. brigitte.buscher@tno.triskelion.nl.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Buscher
authors.forename: Sirpa
authors.initials: S
authors.lastname: Laakso
authors.forename: Hermann
authors.initials: H
authors.lastname: Mascher
authors.forename: Klaus
authors.initials: K
authors.lastname: Pusecker
authors.forename: Mira
authors.initials: M
authors.lastname: Doig
authors.forename: Lieve
authors.initials: L
authors.lastname: Dillen
authors.forename: Winfried
authors.initials: W
authors.lastname: Wagner-Redeker
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfeifer
authors.forename: Pascal
authors.initials: P
authors.lastname: Delrat
authors.forename: Philip
authors.initials: P
authors.lastname: Timmerman
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods / Q000592:standards; D001798:Blood Proteins / Q000032:analysis* / Q000378:metabolism*; D015195:Drug Design; D055808:Drug Discovery / Q000379:methods* / Q000592:standards; D006801:Humans; D011485:Protein Binding
chemical_list: D001798:Blood Proteins