title: Overview of Respiratory Studies to Support ICH S7A.
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.
authors.affiliation: Independent Toxicology/Safety Pharmacology Consultant, Columbia, MO, USA, stonerookconsulting@gmail.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Stonerook
mesh_terms: D000403:Airway Resistance / Q000187:drug effects; D000818:Animals; D004353:Drug Evaluation, Preclinical; D006801:Humans; D008168:Lung / Q000033:anatomy & histology / Q000502:physiology; D009991:Oscillometry; D010100:Oxygen / Q000097:blood; D010991:Plethysmography; D012119:Respiration / Q000187:drug effects*
chemical_list: D010100:Oxygen