Projecting human pharmacokinetics of monoclonal antibodies from nonclinical data: comparative evaluation of prediction approaches in early drug development.

Wang, Jing; Iyer, Suhasini; Fielder, Paul J; Davis, John D; Deng, Rong

Wang, Jing; Iyer, Suhasini; Fielder, Paul J; Davis, John D; Deng, Rong.

Affiliation

Wang J; Global DMPK, Takeda California, San Diego, CA, USA.
Iyer S; Tesaro, Inc., Waltham, MA, USA.
Fielder PJ; Genentech Research and Early Development, Genentech Inc., South San Francisco, CA, USA.
Davis JD; AbbVie Biotherapeutics, Redwood City, CA, USA.
Deng R; Genentech Research and Early Development, Genentech Inc., South San Francisco, CA, USA.

Biopharm Drug Dispos ; 37(2): 51-65, 2016 Mar.

Article in En | MEDLINE | ID: mdl-25869767

Subject(s)

Antibodies, Monoclonal/pharmacokinetics; Animals; Antibodies, Monoclonal/pharmacology; Decision Trees; Drug Evaluation, Preclinical; Humans; Models, Biological

Key words

allometry scaling; monoclonal antibody; pharmacokinetics; species-invariant time method; target-mediated drug disposition

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Full text: 1 Database: MEDLINE Main subject: Antibodies, Monoclonal Type of study: Prognostic_studies / Risk_factors_studies Language: En Journal: Biopharm Drug Dispos Year: 2016 Type: Article Affiliation country: United States

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