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Safety Pharmacology Evaluation of Biopharmaceuticals

  • Chapter
Principles of Safety Pharmacology

Part of the book series: Handbook of Experimental Pharmacology ((HEP,volume 229))

Abstract

Biotechnology-derived pharmaceuticals or biopharmaceuticals (BPs) are molecules such as monoclonal antibodies, soluble/decoy receptors, hormones, enzymes, cytokines, and growth factors that are produced in various biological expression systems and are used to diagnose, treat, or prevent various diseases. Safety pharmacology (SP) assessment of BPs has evolved since the approval of the first BP (recombinant human insulin) in 1982. This evolution is ongoing and is informed by various international harmonization guidelines. Based on these guidelines, the potential undesirable effect of every drug candidate (small molecule or BP) on the cardiovascular, central nervous, and respiratory systems, referred to as the “core battery,” should be assessed prior to first-in-human administration. However, SP assessment of BPs poses unique challenges such as choice of test species and integration of SP parameters into repeat-dose toxicity studies. This chapter reviews the evolution of SP assessment of BPs using the approval packages of marketed BPs and discusses the past, current, and new and upcoming approach and methods that can be used to generate high-quality data for the assessment of SP of BPs.

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Authors and Affiliations

  1. Global Patient Safety, Global Regulatory Affairs & Safety, Amgen Inc, Thousand Oaks, CA, USA

    Hamid R. Amouzadeh

  2. Integrated Discovery & Safety Pharmacology, Amgen Inc, Thousand Oaks, CA, USA

    Michael J. Engwall & Hugo M. Vargas

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  1. Hamid R. Amouzadeh
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  2. Michael J. Engwall
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  3. Hugo M. Vargas
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Correspondence to Hugo M. Vargas .

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Editors and Affiliations

  1. Drug Safety Sciences, Johnson & Johnson PR&D, Raritan, New Jersey, USA

    Michael K. Pugsley

  2. Cardiovascular Division, Faculty of Life Sciences & Medicine, St Thomas' Hospital, King's College London, Rayne Institute, London, United Kingdom

    Michael J Curtis

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Amouzadeh, H.R., Engwall, M.J., Vargas, H.M. (2015). Safety Pharmacology Evaluation of Biopharmaceuticals. In: Pugsley, M., Curtis, M. (eds) Principles of Safety Pharmacology. Handbook of Experimental Pharmacology, vol 229. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-46943-9_15

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