title: Should clinical pharmacokinetic bridging studies between Caucasian and Asian populations be required for approval of monoclonal antibodies?
authors.affiliation: Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, LLC, Malvern, PA, USA.
authors.forename: Honghui
authors.initials: H
authors.lastname: Zhou
authors.forename: Yuko
authors.initials: Y
authors.lastname: Tsukamoto
authors.forename: Hugh M
authors.initials: HM
authors.lastname: Davis
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000493:pharmacokinetics* / Q000627:therapeutic use; D044466:Asian People; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D004347:Drug Interactions; D006801:Humans; D044465:White People
chemical_list: D000911:Antibodies, Monoclonal