Surrogate approaches in development of monoclonal antibodies.

Abstract:

:When cross-reactivity of a lead antibody across species is limited, antibody development programs require the generation of surrogate molecules or surrogate animal models necessary for the conduct of preclinical pharmacology and safety studies. When surrogate approaches are employed, the complexities and challenges for translation of preclinical safety and efficacy results to the clinic are undoubtedly enhanced. Because there are no currently established criteria or regulatory guidance regarding the application of surrogate approaches, a science-based strategy for translation of preclinical information to the clinic is vital for effective development of the lead antibody.

journal_name

Drug Discov Today

journal_title

Drug discovery today

authors

Bornstein GG,Klakamp SL,Andrews L,Boyle WJ,Tabrizi M

doi

10.1016/j.drudis.2009.09.014

subject

Has Abstract

pub_date

2009-12-01 00:00:00

pages

1159-65

issue

23-24

eissn

1359-6446

issn

1878-5832

pii

S1359-6446(09)00343-2

journal_volume

14

pub_type

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