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Drug Discovery and Evaluation: Methods in Clinical Pharmacology pp 1–7Cite as

Pharmacodynamic Evaluation: Inflammation/Immunology

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Abstract

In any drug development including those for candidates in acute and chronic inflammation and any other immunological disbalance, distinct types of pharmacological studies are a regulatory requirement. Together clinical and nonclinical data are required to characterize a novel drug candidate adequately. These requirements were summarized, outlined, and exemplified in this chapter as follows:

  • Primary pharmacology describes the mode of action of the drug candidate with respect to its therapeutic target.

  • Secondary pharmacology: Studies on secondary pharmacology look deeper into the biochemical and physiological effects of a drug and the mode of action that is not directly related to the desired therapeutic target (general pharmacology studies).

  • Safety pharmacology has a focus on the impact of a drug candidate in and above the therapeutic range on the function of organ systems.

  • Immunological safety assessment: First-in-human studies.

  • Immunotoxicology

As there is no international consensus on definitions of the terms, the attribution of either type of studies may sometimes be ambiguous. It is impossible to separate immunotoxicology studies required by regulatory agencies basically from the pharmacodynamics of a drug. An initial package of such pharmacological studies is a prerequisite for first-in-human studies for novel drugs.

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Author information

Authors and Affiliations

  1. Corporate R&D, Biotest AG, Dreieich, Germany

    Jörg Schüttrumpf & Matthias Germer

Authors
  1. Jörg Schüttrumpf
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  2. Matthias Germer
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Corresponding author

Correspondence to Jörg Schüttrumpf .

Editor information

Editors and Affiliations

  1. CorDynamics , Dieburg, Germany

    Franz J. Hock

  2. CorDynamics , Chicago, Illinois, USA

    Michael R. Gralinski

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Schüttrumpf, J., Germer, M. (2018). Pharmacodynamic Evaluation: Inflammation/Immunology. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_34-1

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  • DOI: https://doi.org/10.1007/978-3-319-56637-5_34-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-56637-5

  • Online ISBN: 978-3-319-56637-5

  • eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences

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