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Review of the Technical, Toxicological, and PKPD Considerations for Conducting Inhalation Toxicity Studies on Biologic Pharmaceuticals—The Outcome of a Cross-Industry Working Group Survey

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• Nikula KJ et al. 2014.  STP Position Paper: Interpreting the Significance of Increased Alveolar Macrophages in Rodents following Inhalation of Pharmaceutical Materials.Toxicologic Pathology, 42, 472

• Lewis, DJ, Beck SL, Williams TC.  2014.  Foamy Macrophage Responses in the Rat Lung following Exposure to Inhaled Pharmaceuticals: A simple, pragmatic approach for inhaled drug development. Journal of Applied Toxicology, 34, 4, 391-331

• Owen K.  2013.  Regulatory toxicology considerations for the development of inhaled pharmaceuticals. Drug Chem Toxicology, 36(1): 109–118.

• Forbes B, Asgharian B, Dailey LA, et al.  (2011).  Challenges in inhaled product development and opportunities for open innovation.  Adv Drug Deliv Rev, 63 (1-2), 69-87

• McElroy, M.C. 2012. Inhaled biopharmaceutical drug development: nonclinical considerations and case studies. Inhalation Toxicology, 25. 219-232.

• Jones, D.R. 2013. Association of Inhalation Toxicologists (AIT) review of regulatory aspects for inhalation toxicology studies. Inhalation Toxicology, 25 84-90.

• Alexander DJ, et al. 2008. Association of Inhalation Toxicologists (AIT) Working Party for Standard Delivered Dose Calculation and Expression in Non-Clinical Aerosol Inhalation Toxicology Studies with Pharmaceuticals. Inhalation Toxicology, 20. 1179-1189.

• Kaufmann W, Bader R, Ernst H, et al.  2009.  1st International ESTP Expert Workshop: “Larynx squamous metaplasia”. A re-consideration of morphology and diagnostic approaches in rodent studies and its relevance for human risk assessment.  Exp Tox Path, 61, 591-603.

• Treatise on Pulmonary Toxicology Vol 1. Comparative Biology of the normal lung. Ed. RA Parent. CRC Press.1991.

• Raabe O.G., Al-Bayati M.A., Teague, S.V. and Rasolt A. 1988.  Regional deposition of inhaled monodisperse coarse and fine aerosol particles in small laboratory animals. Ann. Occup. Hyg, 32 53 - 63.

• Schlesinger R.B, 1985.  Comparative deposition of inhaled aerosols in experimental animals and humans: a review. J.Tox Env Hlth, 15 197 - 214.

• Biology Data Handbook. 2nd Edition. Volume III. Ed. Altman PL and Dittmer DS. 1974.

• Dahl AR.  1995.  Metabolic charateristics of the respiratory tract.  In: Concepts in inhalation toxicology (2nd ed). Taylor and Francis, Washington DC.  pp141-160,

• Driscoll KE, Costa DL, Hatch G, et al.  2000.  Intratracheal instillation as an exposure technique for the evaluation of respiratory tract toxicity: Uses and limitations.  Tox Sci, 55, 24-35