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Expert Opinion on Drug Discovery Volume 5, 2010 - Issue 1
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Challenges of general safety evaluations of biologics compared to small molecule pharmaceuticals in animal models

Rakesh Dixit MedImmune LLC, One MedImmune Way, Biologics Safety Assessment, Gaithersburg, MD 20878, USA
, PhD DABT (Senior Director and Head) ,
Laurie A Iciek MedImmune LLC, One MedImmune Way, Biologics Safety Assessment, Gaithersburg, MD 20878, USA +1 301 398 5903; +1 301 398 9387; [email protected]
, PhD,
Kathleen McKeever MedImmune LLC, One MedImmune Way, Biologics Safety Assessment, Gaithersburg, MD 20878, USA +1 301 398 5903; +1 301 398 9387; [email protected]
, PhD DABT &
Patricia Clare Ryan MedImmune LLC, One MedImmune Way, Biologics Safety Assessment, Gaithersburg, MD 20878, USA +1 301 398 5903; +1 301 398 9387; [email protected]
, PhD (Principal Toxicologist)
Pages 79-94 | Published online: 19 Dec 2009

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Christer Gottfridsson, Seva Panfilov, Ahmad Ebrahimi, Emery Gigger, Chris Pollard, Simon Henderson, Philip Ambery & Joel S. Raichlen. (2017) Drug-induced blood pressure increase – recommendations for assessment in clinical and non-clinical studies. Expert Opinion on Drug Safety 16:2, pages 215-225.
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Hugo M Vargas, Hamid R Amouzadeh & Michael J Engwall. (2013) Nonclinical strategy considerations for safety pharmacology: evaluation of biopharmaceuticals. Expert Opinion on Drug Safety 12:1, pages 91-102.
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Marlous Kooijman, Peter J.K. van Meer, Ellen H.M. Moors & Huub Schellekens. (2012) Thirty years of preclinical safety evaluation of biopharmaceuticals: did scientific progress lead to appropriate regulatory guidance?. Expert Opinion on Drug Safety 11:5, pages 797-801.
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Magali R. Guffroy & Xiantang Li. 2023. Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology. Haschek and Rousseaux's Handbook of Toxicologic Pathology, Volume 2 : Safety Assessment Environmental Toxicologic Pathology 95 123 .
Kaixing Zeng, Lili Han & Yiyun Chen. (2022) Endogenous Proteins Modulation in Live Cells with Small Molecules and Light. ChemBioChem 23:21.
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Lauren E. Himmel, Kristin Lewis Wilson, Sara F. Santagostino & Brad Bolon. 2022. Haschek and Rousseaux's Handbook of Toxicologic Pathology. Haschek and Rousseaux's Handbook of Toxicologic Pathology 859 924 .
Michael J. Engwall, Weston Sutherland & Hugo M. Vargas. 2022. Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays 1 16 .
Lotte A. Minnema, Thijs J. Giezen, Helga Gardarsdottir, Toine C. G. Egberts, Hubert G. M. Leufkens & Aukje K. Mantel‐Teeuwisse. (2019) Post‐marketing dosing changes in the label of biologicals. British Journal of Clinical Pharmacology 85:4, pages 715-721.
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Brad Bolon, Wallace Baze, Christopher J Shilling, Kendy L Keatley, Daniel J Patrick & Kenneth A Schafer. (2018) Good Laboratory Practice in the Academic Setting: Fundamental Principles for Nonclinical Safety Assessment and GLP-Compliant Pathology Support When Developing Innovative Biomedical Products. ILAR Journal 59:1, pages 18-28.
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Ariane G. S. Araujo, Helena H. L. Borba, Fernanda S. Tonin, Luana Lenzi, Rafael Venson, Roberto Pontarolo & Astrid Wiens. (2018) Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS). BioDrugs 32:4, pages 377-390.
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Patrick G. Holder & David Rabuka. 2016. Biosimilars of Monoclonal Antibodies. Biosimilars of Monoclonal Antibodies 591 640 .
Hamid R. Amouzadeh, Michael J. Engwall & Hugo M. Vargas. 2015. Principles of Safety Pharmacology. Principles of Safety Pharmacology 385 404 .
D. Mendes, C. Alves & F. Batel-Marques. (2014) Safety profiles of adalimumab, etanercept and infliximab: a pharmacovigilance study using a measure of disproportionality in a database of spontaneously reported adverse events. Journal of Clinical Pharmacy and Therapeutics 39:3, pages 307-313.
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