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Immunotoxicology

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Nijkamp and Parnham's Principles of Immunopharmacology

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Abstract

Pharmaceuticals for human use comprise a very wide variety of product types. These include traditional products (i.e. chemically synthesized or derived from natural resources) as well as biological products (such as vaccines and blood products isolated from biological sources) and biotechnology-derived pharmaceuticals (such as peptide/protein products manufactured by recombinant DNA techniques, monoclonal antibodies and gene therapy products). In the interest of the public, these medicinal products are subject to worldwide regulatory control by government authorities. The major objective of this regulation is to ensure that the benefit of the products to the patients is not outweighed by their adverse effects. To achieve this goal, the authorities carefully assess the balance between efficacy and safety. If this balance is positive, they allow marketing. To support applications for marketing authorization, the pharmaceutical industry, therefore, has to submit scientific data which prove that their products are efficacious and acceptably safe in the proposed therapeutic indication. Furthermore, the pharmaceutical quality of the products applied for has to meet high standards.

Final manuscript submitted on May 07, 2018.

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Author information

Authors and Affiliations

  1. Immunotoxicology, Institute for Risk Assessment Sciences (IRAS), Utrecht University, Utrecht, The Netherlands

    Raymond Pieters

  2. University of Applied Sciences Utrecht, Utrecht, The Netherlands

    Raymond Pieters

  3. Section on Pharmacology, Toxicology and Kinetics, Medicines Evaluation Board, Utrecht, The Netherlands

    Jan Willem van der Laan

  4. Division on Toxicology, Leiden Academic Center for Drug Research, Leiden, The Netherlands

    Jan Willem van der Laan

  5. Department of Toxicogenomics, Maastricht University, Maastricht, The Netherlands

    Henk van Loveren

Authors
  1. Raymond Pieters
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  2. Jan Willem van der Laan
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  3. Henk van Loveren
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Corresponding author

Correspondence to Jan Willem van der Laan .

Editor information

Editors and Affiliations

  1. Translational Drug Validation, Fraunhofer IME-TMP and Goethe University Frankfurt, Frankfurt am Main, Germany

    Michael J. Parnham

  2. Utrecht University, Utrecht, The Netherlands

    Frans P. Nijkamp

  3. The Queen’s Medical Research Institute, MRC Centre for Inflammation Research, University of Edinburgh, Edinburgh, UK

    Adriano G. Rossi

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Pieters, R., van der Laan, J.W., van Loveren, H. (2019). Immunotoxicology. In: Parnham, M., Nijkamp, F., Rossi, A. (eds) Nijkamp and Parnham's Principles of Immunopharmacology. Springer, Cham. https://doi.org/10.1007/978-3-030-10811-3_37

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