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Principles of Safety Pharmacology pp 131–148Cite as

Overview of Respiratory Studies to Support ICH S7A

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

Abstract

Tests of pulmonary function are useful tools for evaluating the potential for compounds to produce toxicity affecting the pulmonary system. Insults to the pulmonary system (i.e., due to drugs, biologics, toxins) can cause detectable dysfunction through multiple mechanisms. Manifestation of the response to insults will depend on the component(s) involved and the compensatory mechanism(s) initiated. The purpose of this chapter is to introduce the concepts of pulmonary testing as it is applied to the preclinical evaluation of pharmaceutical test articles. The topics will include the techniques and methods that have been developed for use in nonclinical (animal) subjects and the parameters that are routinely measured.

Keywords

  • Blood gases
  • Compliance
  • ICH S7A
  • Oscillometry
  • Oxygen saturation
  • Plethysmography
  • Pneumotachograph
  • Resistance
  • Respiratory inductance plethysmography (RIP)
  • Respiratory rate
  • Tidal volume

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Authors and Affiliations

  1. Independent Toxicology/Safety Pharmacology Consultant, Columbia, MO, USA

    Michael Stonerook

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  1. Michael Stonerook
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Correspondence to Michael Stonerook .

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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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Stonerook, M. (2015). Overview of Respiratory Studies to Support ICH S7A. 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_6

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