Considerations for toxicology studies of respiratory drug products

Regulatory Toxicology and Pharmacology : RTP
J J DeGeorgeA S Taylor

Abstract

The standard approaches for the preclinical development of chronically administered drugs also apply to most respiratory drugs. Modifications from the standard preclinical development plan, however, may be necessary if the drug is administered intranasally or by inhalation. Administration by these routes may result in airway toxicity and the intended patient population is often particularly susceptible. Current and former representatives of the Division of Pulmonary Drug Products (CDER, U.S. FDA) present this article to describe general principles of preclinical development for respiratory drug indications. The article addresses drugs intended for administration by the intranasal or inhalation routes. The article describes the types of studies recommended, considers the initial human dose, and discusses dose-escalation strategies in clinical trials. Other areas of special concern with intranasal or inhalation administration include immunotoxicity, reproductive toxicity, types of dosing apparatus, excipients and extractables, and formulation changes. The approaches described in this article are intended as general information and should be adapted to the scientific considerations and circumstances of a particular drug under deve...Continue Reading

References

Aug 15, 1990·Journal of the National Cancer Institute·J M CollinsB A Chabner
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Citations

May 9, 2014·Expert Opinion on Drug Metabolism & Toxicology·Amanda J Hayes, Shahnaz Bakand
Apr 28, 2012·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Christophe DuretKarim Amighi
Apr 2, 2011·International Journal of Pharmaceutics·Regina Scherliess
Nov 9, 2000·Regulatory Toxicology and Pharmacology : RTP·P Baldrick
Oct 12, 2000·Toxicologic Pathology·J Pauluhn, U Mohr
Mar 8, 2008·Journal of Biomaterials Science. Polymer Edition·M J de Jesús ValleA Sánchez Navarro
Feb 1, 2007·Current Protocols in Toxicology·Michael A Dorato, Lorrene A Buckley
Apr 1, 2006·Current Protocols in Pharmacology·Michael A Dorato, Lorrene A Buckley
Jul 10, 2020·Advanced Drug Delivery Reviews·T SécherN Heuzé-Vourc'h
Apr 29, 2015·Molecular Pharmaceutics·R K Wolff
May 30, 2019·Journal of Cystic Fibrosis : Official Journal of the European Cystic Fibrosis Society·Brandon BanaschewskiThomas Hofmann

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