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Utilizing PK and PD Biomarkers to Guide the First-in-Human Starting Dose Selection of MTBT1466A: A Novel Humanized Monoclonal Anti-TGFß3 Antibody for the Treatment of Fibrotic Diseases.
Yadav, Rajbharan; Sukumaran, Siddharth; Lutman, Jeff; Mitra, Mayur S; Halpern, Wendy; Sun, Tianhe; Setiadi, A Francesca; Neighbors, Margaret; Sheng, X Rebecca; Yip, Victor; Shen, Ben-Quan; Liu, Chang; Han, Lyrialle; Ovacik, Ayse Meric; Wu, Yan; Glickstein, Sara; Kunder, Rebecca; Arron, Joseph R; Pan, Lin; Kamath, Amrita V; Stefanich, Eric G.
Affiliation
  • Yadav R; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA. Electronic address: yadavr13@gene.com.
  • Sukumaran S; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA.
  • Lutman J; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA.
  • Mitra MS; Safety Assessment, Genentech Inc., South San Francisco, CA, USA.
  • Halpern W; Safety Assessment, Genentech Inc., South San Francisco, CA, USA.
  • Sun T; Immunology Discovery, Genentech Inc., South San Francisco, CA, USA.
  • Setiadi AF; BioAnalytical Sciences, Genentech Inc., South San Francisco, CA, USA.
  • Neighbors M; Translational Medicine, Genentech Inc., South San Francisco, CA, USA.
  • Sheng XR; Translational Medicine, Genentech Inc., South San Francisco, CA, USA.
  • Yip V; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA.
  • Shen BQ; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA.
  • Liu C; BioAnalytical Sciences, Genentech Inc., South San Francisco, CA, USA.
  • Han L; Clinical Pharmacology, Genentech Inc., South San Francisco, CA, USA.
  • Ovacik AM; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA.
  • Wu Y; Antibody Engineering, Genentech Inc., South San Francisco, CA, USA.
  • Glickstein S; Early Clinical Development, Genentech Inc, South San Francisco, CA, USA.
  • Kunder R; Early Clinical Development, Genentech Inc, South San Francisco, CA, USA.
  • Arron JR; Immunology Discovery, Genentech Inc., South San Francisco, CA, USA.
  • Pan L; Clinical Pharmacology, Genentech Inc., South San Francisco, CA, USA.
  • Kamath AV; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA.
  • Stefanich EG; Preclinical and Translational Pharmacokinetics and Pharmacodynamics, Genentech Inc., South San Francisco, CA, USA. Electronic address: erics@gene.com.
J Pharm Sci ; 112(11): 2910-2920, 2023 Nov.
Article in En | MEDLINE | ID: mdl-37429356
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Prognostic_studies Language: En Journal: J Pharm Sci Year: 2023 Document type: Article Country of publication: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Prognostic_studies Language: En Journal: J Pharm Sci Year: 2023 Document type: Article Country of publication: United States