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Dust Load Testing
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Suggested Reading

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

  • Naheed Rehman and Simon Moore. 2021. An overview of the state of the regulatory and preclinical requirements for nanomaterials including medical devices. Integrated Environmental Assessment and Management, Volume 17, Issue 6, November 2021, Pages 1098-1104

  • Jeffrey S. Tepper et al. 2016. Symposium Summary: Breathe In, Breathe Out, Its Easy: What You Need to Know About Developing Inhaled Drugs. International Journal of Toxicology, Vol. 35(4) 376-392

  • 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

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