Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges
暂无分享,去创建一个
Jennifer Sims | Ian Ragan | Kathryn Chapman | Paul Baldrick | M. Leach | Kathryn L Chapman | A. Suitters | A. da Silva | J. Sims | K. De Smet | I. Ragan | Karen De Smet | Akosua Adjei | Antonio da Silva | Richard DiCicco | Seung Suh Hong | David Jones | Michael W. Leach | James McBlane | Praveen Reddy | Donald I. H. Stewart | Amanda Suitters | P. Baldrick | SeungSuh Hong | D. Stewart | A. Adjei | R. Dicicco | J. McBlane | Praveen Reddy | David Jones
[1] P. Bugelski,et al. Concordance of preclinical and clinical pharmacology and toxicology of monoclonal antibodies and fusion proteins: soluble targets , 2012, British journal of pharmacology.
[2] B. Scallon,et al. Contribution of FcRn binding to intestinal uptake of IgG in suckling rat pups and human FcRn-transgenic mice. , 2013, American journal of physiology. Gastrointestinal and liver physiology.
[4] P. Bugelski,et al. Concordance of preclinical and clinical pharmacology and toxicology of therapeutic monoclonal antibodies and fusion proteins: cell surface targets , 2012, British journal of pharmacology.
[5] M. Leach,et al. Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280014 and Trastuzumab (Herceptin®) , 2014, BioDrugs.
[6] Martin Schiestl,et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals , 2011, Nature Biotechnology.
[7] Ian Ragan,et al. Preclinical development of monoclonal antibodies , 2009, mAbs.
[8] J. Chaparro-Riggers,et al. The neonatal Fc receptor (FcRn) binds independently to both sites of the IgG homodimer with identical affinity , 2015, mAbs.
[9] C. Schneider,et al. Biosimilars entering the clinic without animal studies , 2014, mAbs.
[10] I. Sandlie,et al. Cross-species Binding Analyses of Mouse and Human Neonatal Fc Receptor Show Dramatic Differences in Immunoglobulin G and Albumin Binding* , 2009, The Journal of Biological Chemistry.
[11] Huub Schellekens,et al. Contribution of animal studies to evaluate the similarity of biosimilars to reference products. , 2015, Drug discovery today.
[12] Jennifer Sims,et al. The design of chronic toxicology studies of monoclonal antibodies: implications for the reduction in use of non-human primates. , 2012, Regulatory toxicology and pharmacology : RTP.
[13] M. Leach,et al. Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280586 and Rituximab (MabThera®) , 2014, Toxicologic pathology.
[14] Joy A. Cavagnaro,et al. Preclinical safety evaluation of biotechnology-derived pharmaceuticals , 2002, Nature Reviews Drug Discovery.
[15] J. Bussiere. Species selection considerations for preclinical toxicology studies for biotherapeutics. , 2008, Expert opinion on drug metabolism & toxicology.
[16] R. Ober,et al. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. , 2001, International immunology.
[17] Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues , 2012 .
[18] Carol F. Kirchhoff,et al. Key considerations in the preclinical development of biosimilars. , 2015, Drug discovery today.
[19] Ellen H.M. Moors,et al. The value of non-human primates in the development of monoclonal antibodies , 2013, Nature Biotechnology.
[20] Kathryn L Chapman,et al. Preclinical safety testing of monoclonal antibodies: the significance of species relevance , 2007, Nature Reviews Drug Discovery.
[21] H. Malhotra,et al. Global regulatory landscape of biosimilars: emerging and established market perspectives , 2015 .