Safety assessment of therapeutic agents administered by the respiratory routes

Inhalation Toxicology, Third Edition

Volumn , Issue , 2014, Pages 537-579

  Gad, Shayne C ^a  

^a Gad Consulting Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85019560781     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b16781     Document Type: Chapter

References (204)

1. ACGIH. (2006). Documentation of the Threshold Limit Values and Biological Exposure Indices, 7th edn. American Conference of Governmental Industrial Hygienists, Cincinnati, OH.
2. Adams, E.M., Spencer, H.C., Rowe, V.K., and Irish, D.D. (1950). Vapor toxicity of 1,1,1,-trichloroethane (methylchloroform) determined by experiments on laboratory animals. Arch. Ind. Hyg. Occup. Med. 1: 225-236.
3. Adams, E.M., Spencer, H.C., Rowe, V.K., McCollister, D.D., and Irish, D.D. (1952). Vapor toxicity of carbon tetrachloride determined by experiments on laboratory animals. Arch. Ind. Hyg. Occup. Med. 6: 50-66.
4. Agnew, J.E. (1984). Physical properties and mechanisms of deposition of aerosols. In: Aerosols and the Lung, Clinical Aspects (S.W. Clarke and D. Pavia, eds.). Butterworth, London, U.K., pp. 49-68.
5. Agu, R.U., Jorissen, M., Kinget, R., Verbeke, N., and Augustigns, P. (2002). Alternatives to in vivo nasal toxicological screening for nasally administered drugs. STP Pharma Sci. 12: 13-22.
6. Akoun, G.M. (1989). Natural history of drug-induced pneumonitis. In: Drug Induced Disorders, Volume 3: Treatment Induced Respiratory Disorders (G.M. Akoun and J.P. White, eds.). Elsevier Scientific Publishers B.V., New York, pp. 3-9.
7. Alarie, Y. (1966). Irritating properties of airborne material to the upper respiratory tract. Arch. Environ. Health 13: 433-449.
8. Alarie, Y. (1973). Sensory irritation by airborne chemicals. CRC Crit. Rev. Toxicol. 2: 299-363.
9. Alarie, Y. (1981a). Toxicological evaluation of airborne chemical irritants and allergens using respiratory reflex reactions. In: Inhalation Toxicology and Technology (B.K.J. Leong, ed.). Ann Arbor Science, Ann Arbor, MI, pp. 207-231.
10. Alarie, Y. (1981b). Bioassay for evaluating the potency of airborne sensory irritants and predicting acceptable levels of exposure in man. Food Cosmet. Toxicol. 19: 623-626.
11. Alarie, Y. and Luo, J.E. (1984). Sensory irritation by airborne chemicals: A basis to establish acceptable levels of exposure. In: Toxicology of the Nasal Passages (C.S. Barrow, ed.). Hemisphere, New York, pp. 91-100.
12. Alarie, Y., Kane, L., and Barrow, C. (1980). Sensory irritation: The use of an animal model to establish acceptable exposure to airborne chemical irritants. In: Toxicology: Principles and Practice 1 (A.L. Reeves, ed.). John Wiley & Son, New York, pp. 48-92.
13. Aldridge, S. (2003). Inhaled antibodies work better for chronic sinusitis. My Health and Age, March 4, 2003, pp. 18-23.
14. Altman, P.L. and Dittmer, D.S. (1974). Biological Data Book, Vol. III. Federation of American Societies for Experimental Biology, Bethesda, MD.
15. Amdur, M.O. and Mead, J. (1958). Mechanics of respiration in unanesthetized guinea pigs. Am. J. Physiol. 192: 364-368.
16. American Thoracic Society. (1991). Lung function testing: Selection of reference values and interpretative strategies. Am. Rev. Respir. Dis. 144: 1202-1218.
17. Andersen, M.E., French, J.E., Gargas, M.L., Jones, R.A., and Jenkins, L.J. Jr. (1979). Saturable metabolism and the acute toxicity of 1,1-dichloroethylene. Toxicol. Appl. Pharmacol. 47: 385-393.
18. Aso, Y., Yoneda, K., and Kikkawa, Y. (1976). Morphologic and biochemical study of pulmonary changes induced by bleomycin in mice. Lab. Invest. 35: 558-568.
19. Aviado, D.M. (1981). Comparative cardiotoxicity of fluorocarbons. In: Cardiac Toxicology, Vol. II (T. Balazs, ed.). CRC Press, Boca Raton, FL, pp. 213-222.
20. Aviado, D.M. and Micozzi, M.S. (1981). Fluorine-containing organic compounds. In: Patty’s Industrial Hygiene and Toxicology, Vol. 2B (G.D. Clayton and F.E. Clayton, eds.). Wiley, New York, pp. 3071-3115.
21. Balazs, T. (1981). Cardiotoxicity of adrenergic bronchodilator and vasodilating antihypertensive drugs. In: Cardiac Toxicology, Vol. II (T. Balazs, ed.). CRC Press, Boca Raton, FL, pp. 61-73.
22. Barrow, C.S. (1986). Toxicology of the Nasal Passages. Hemisphere, New York.
23. Bell, K.A. (1978). Local particle deposition in respiratory airway models. In: Recent Developments in Aerosol Science (D.T. Shaw, ed.). Wiley, New York, pp. 97-134.
24. Bice, D.E. (1985). Methods and approaches to assessing immunotoxicology of the lower respiratory tract. In: Immunotoxicology and Immunopharmacology (J.H. Dean, M.I. Luster, A.E. Munson, and H.A. Amos, eds.). Raven Press, New York, pp. 145-157.
25. Boggs, D.F. (1992). Comparative control of respiration. In: Comparative Biology of the Normal Lung, Vol. I (R.A. Parent, ed.). CRC Press, Boca Raton, FL, pp. 309-350.
26. Borison, H.L. (1977). Central nervous system depressants: Control-systems approach to respiratory depression. Pharmacol. Ther. B 3: 211-226.
27. Brain, J.D. (1971). The effects of increased particles on the number of alveolar macrophages. In: Inhaled Particles III Proceedings of ISOHS Symposium, Unwin Brothers Ltd., London, U.K., pp. 220-223.
28. Brain, J.D., Knudson, D.E., Sorokin, S.P., and Davis, M.A. (1976). Pulmonary distribution of particles given by intratracheal instillation or be aerosol inhalation. Environ. Res. 11: 13-33.
29. Brown, L.K. and Miller, A. (1987). Full lung volumes: Functional residual capacity, residual volume and total lung capacity. In: Pulmonary Function Tests: A Guide for the Student and House Officer (A. Miller, ed.). Grune & Stratton, Inc., New York, pp. 53-58.
30. Burham, S.R. (2002). The ideal nasal corticosteroid: Balancing efficacy, safety and patient preference. Clin. Exp. Allergy Rev. 2: 32-37.
31. CDER. (2002). Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products-Chemistry, Manufacturing and Control Documentation. Food and Drug Administration, Washington, DC.
32. Chan, T.L. and Lippmann, M. (1980). Experimental measurements and empirical modelling of the regional deposition of inhaled particles in humans. Am. Ind. Hyg. Assoc. J. 41: 399-409.
33. Chenoweth, M.B., Leong, B.K.J., Sparschu, G.L., and Torkelson, T.R. (1972). Toxicities of methoxyflurane, halothane and diethyl ether in laboratory animals on repeated inhalation at subanesthetic concentrations. In: Cellular Biology and Toxicity of Anesthetics (B.R. Fink, ed.). Williams & Wilkins, Baltimore, MD, pp. 275-284.
34. Cherniack, N.S. (1988). Disorders in the control of breathing: Hyperventilation syndromes, In: Textbook of Respiratory Medicine (J.F. Murray and J.A. Nadal, eds.). W.B. Saunders Co., Philadelphia, PA, pp. 1861-1866.
35. Clarke, S.W. and Pavia, D. (eds.) (1984). Aerosol and the Lung: Clinical and Experimental Aspects. Butterworth, London, U.K.
36. Cox, J.S.G., Beach, J.E., Blair, A.M.J.N., Clarke, A.J., King, J., Lee, T.B., Loveday, D.E.E. et al. (1970). Disodium cromoglycate. Adv. Drug. Res. 5: 115-196.
37. Curry, S.H., Taylor, A.J., Evans, S., Godfrey, S., and Zeidifard, E. (1975). Disposition of disodium cromoglycate administered in three particle sizes. Br. J. Clin. Pharmacol. 2: 267-270.
38. Dahl, A.R. (1990). Dose concepts for inhaled vapors and gases. Toxicol. Appl. Pharmacol. 103: 185-197.
39. Dallas, C.E., Bruckner, J.V., Maedgen, J.L., and Weir, F.W. (1986). A method for direct measurement of systemic uptake and elimination of volatile organics in small animals. J. Pharmacol. Methods 16: 239-250.
40. Dallas, C.E., Ramanathan, R., Muralidhara, S., Gallo, J.M., and Bruckner, J.V. (1989). The uptake and elimination of 1,1,1-trichloroethane during and following inhalation exposure in rats. Toxicol. App. Pharmacol. 98: 385-397.
41. Dautrebande, L. (1962a). Importance of particle size for therapeutic aerosol efficiency. In: Microaerosols. Academic Press, New York, pp. 37-57.
42. Dautrebande, L. (1962b). Practical recommendation for administering pharmacological aerosols. In: Microaerosols. Academic Press, New York, pp. 86-92.
43. Dautrebande, L. (1962c). Production of liquid and solid micromicellar aerosols. In: Microaerosols. Academic Press, New York, pp. 1-22.
44. Davies, R.J. and Pepys, J. (1975). Asthma due to inhaled chemical agents-The macrolide antibiotic spiramycin. Clin. Allergy 5: 99-107.
45. Davis, B., Marin, M.G., Fischer, S., Graf, P., Widdicombe, J.G., and Nadel, J.A. (1976). New method for study of canine mucus gland secretion in vivo: Cholinergic regulation. Am. Rev. Respir. Dis. 113: 257 (abstract).
46. Davis, C.N., Heyder, J., and Subba Ramv, M.C. (1972). Breathing of half micron aerosols. I. Experimental. J. Appl. Physiol. 32: 591-600.
47. Dennis, W.L. (1961). The discussion of a paper by C.N. Davis: A formalized anatomy of the human. In: Inhaled Particles and Vapours, (C.N. Davis, ed.). Pergamon Press, London, U.K., p. 88.
48. Diamond, L. and O’Donnell, M. (1977). Pulmonary mechanics in normal rats. J. Appl. Physiol. 43: 942-948.
49. Doe, J.E. and Tinston, D.J. (1981). Novel chamber for long-term inhalation studies. In: Inhalation Toxicology and Technology (K.J. Leong, ed.). Ann Arbor Science, Ann Arbor, MI, pp. 472-493.
50. Dorato, M.A. (1994). Toxicological evaluation of intranasal peptide and protein drugs. Drugs Pharm. Sci. 62: 345-381.
51. Drazen, J.M. (1984). Physiological basis and interpretation of indices of pulmonary mechanics. Environ. Health Perspect. 56: 3-9.
52. Drew, R.T. and Laskin, S. (1973). Environmental inhalation chambers. In: Methods of Animal Experimentation, Vol. IV. Academic Press, New York, pp. 1-41.
53. Drew, R.T. and Lippmann, M. (1978). Calibration of air sampling instruments. In: Air Sampling Instruments for Evaluation of Atmospheric Contaminants, 5th edn. American Conference of Governmental Industrial Hygienists, Cincinnati, OH, Section I, pp. 1-32.
54. Durham, S.R. (2002). The ideal nasal corticosteroid: Balancing efficacy, safety and patient preference. Clin. Exp. Allergy Rev. 2: 32-37.
55. Eldridge, F.L. and Millhorn, D.E. (1981). Central regulation of respiration by endogenous neurotransmitters and neuromodulators. Ann. Rev. Physiol. 3: 121-135.
56. Elliot, G.A. and DeYoung E.N. (1970). Intranasal toxicity testing of antiviral agents. Am. N. Y. Acad. Sci. 173: 169-175.
57. Evans, M.J. (1982). Cell death and cell renewal in small airways and alveoli. In: Mechanisms in Respiratory Toxicology, Vol. 1 (H. Witschi and P. Nettesheim, eds.). CRC, Boca Raton, FL, pp. 189-218.
58. Fariba, A., Kellie, M., Stephen, M., Oune, O., Kafi, A., and Mary, H. (2002). Repeated doses of antenatal corticosteroids in animals: A systematic review, Am. J. Obstet. Gynecol. 186: 843-849.
59. Ferin, J. (1977). Effect of particle content of lung on clearance pathways. In: Pulmonary Macrophage and Epithelial Cells (C.L. Sanders, R.P. Schneider, G.E. Dagle, and H.A. Ragan, eds.). Technical Information Center, Energy Research & Development Administration, Springfield, VA, pp. 414-423.
60. Fieldner, A.C., Kazt, S.H., and Kinney, S.P. (1921). Gas masks for gases met in fighting fires. Technical paper no. 248. US Bureau of Mines, Pittsburgh, PA.
61. Gad, S.C. (2009). Drug Safety Evaluation, 2nd edn. Wiley, Hoboken, NJ.
62. Gad, S.C. (2012). Safety Pharmacology, 2nd edn. CRC Press, Boca Raton, FL.
63. Gad, S.C. and Chengelis, C.P. (1998). Acute Toxicology Testing: Perspectives and Horizons, 2nd edn. Academic Press, San Diego, CA, pp. 404-466.
64. Gamsu, G., Singer, M.M., Vincent, H.H., Berry, S., and Nadel, J.A. (1976). Postoperative impairment of mucous transport in the lung. Am. Rev. Respir. Dis. 114: 673-679.
65. Gardner, D.E. and Kennedy Jr., G.L. (1993). Methodologies and technology for animal inhalation toxicology studies. In: Toxicology of the Lung, 2nd edn. (D.E. Gardner, J.D. Crapo, and R.O. McClellan, eds.). Raven Press, New York.
66. Godfrey, S., Zeidifard, E., Brown, K., and Bell, J.H. (1974). The possible site of action of sodium cromoglycate assessed by exercise challenge. Clin. Sci. Mol. Med. 46: 265-272.
67. Haber, F.R. (1924). Funf Vortage aus den jahren 1920-1923, No. 3. Die Chemie im Kriege. Julius Springer, Berlin, Germany.
68. Hafner, R.E., Jr., Watanabe, P.G., and Gehring, P.J. (1975). Preliminary studies on the fate of inhaled vinyl chloride monomer in rats. Am. N. Y. Acad. Sci. 246: 135-148.
69. Hatch, T.F. and Gross, P. (1964). Pulmonary Deposition and Retention of Inhaled Aerosols. Academic Press, New York, pp. 16-17, 51-52, 147-168.
70. Henderson, R. (1988). Use of bronchoalveolar lavage to detect lung damage. In: Toxicology of the Lung (D.E. Gardner, J.D. Crapo, and E.J. Massaro, eds.). Raven Press, New York, pp. 239-268.
71. Henderson, R. (1989). Bronchoalveolar lavage: A tool for assessing the health status of the lung. In: Concepts in Inhalation Toxicology (R.O. McClellan and R.F. Henderson, eds.). Hemisphere, Washington, DC, pp. 414-442.
72. Henderson, R.F. (1984). Use of Bronchoalveolar lavage to detect lung damage. Environ. Health Perspect. 56: 115-129.
73. Henderson, R.F. and Loery, J.S. (1983). Effect of anesthetic agents on lavage fluid parameters used as indicators of pulmonary injury. Lab. Anim. Sci. 33: 60-62.
74. Henderson, R.F., Barr, E.B., and Hotchkiss, J.A. (1991). Effect of exposure rate on response of the lung to inhaled particles. Toxicologists 11: 234 (abstract).
75. Henderson, R.F., Benson, J.M., Hahn, F.F., Hobbs, C.H., Jones, R.K., Mauderly, J.L., McClellan, R.O., and Pickrell, J.A. (1985). New approaches for the evaluation of pulmonary toxicity: Bronchoalveolar lavage fluid analysis. Fundam. Appl. Toxicol. 5: 451-458.
76. Henderson, R.F., Mauderly, J.L., Pickrell, J.A., Hahn, F.F., Muhle, H., and Rebar, A.H. (1987) Comparative study of bronchoalveolar lavage fluid: Effect of species, age, method of lavage. Exp. Lung Res. 1: 329-342.
77. Hensley, M.J., O’Cain, C.F., McFadden, E.R. Jr., and Ingram, R.H. Jr. (1978). Distribution of bronchodilatation in normal subjects: Beta agonist versus atropine. J. Appl. Physicol. 45: 778-782.
78. Heyder, J., Gebhart, J., and Stahlhofen, W. (1980). Inhalation of aerosols: Particle deposition and retention. In: Generation of Aerosols and Facilities for Exposure Experiments (K. Willeke, ed.). Ann Arbor Science, Ann Arbor, MI, pp. 80-99.
79. Heymans, C. (1955). Action of drugs on carotid body and sinus. Pharmacol. Rev. 7: 119-142.
80. Heymans, C. and Niel, E. (1958). The effects of drugs on chemoreceptors. In: Reflexogenic Areas of the Cardiovascular Systems (C. Heymans and E. Neil, eds.). Churchill, Ltd., London, U.K., pp. 192-199.
81. Hiller, F.C., Mazunder, M.K., Wilson, J.D., and R.C. Bone, R.C. (1978). Aerodynamic size distribution of metered dose bronchodilator aerosols. Am. Rev. Respir. Dis. 118: 311-317.
82. Hinds, W.C. (1980). Dry-dispersion aerosol generators. In: Generation of Aerosols and Facilities for Exposure Experiments (K. Willeke, ed.). Ann Arbor Science, Ann Arbor, MI, pp. 171-187.
83. Hirai, S., Yashiki, T., and Mima, H. (1981). Mechanisms for the enhancement of the nasal absorption of insulin by surfactants. Int. J. Pharm. 9: 173-184.
84. Hocking, W.G. and Golde, D.W. (1979). The pulmonary alveolar macrophage. N. Engl. J. Med. 310: 580-587, 639-645.
85. Hodson, M.E., Penketh, A.R., and Batten, J.C. (1981). Aerosol carbenicillin and gentamicin treatment of Pseudomonas aeruginosa infection I patients with cystic fibrosis. Lancet 2: 1137-1139.
86. 2 exposed rabbits. Acta Med. Scand. Suppl. 473: 1-102.
87. Illum, L. and Davis, S.S. (1992). Intranasal insulin. Clinical pharmacokinetics. Clin. Pharmacokinet. 23: 30-41.
88. Indans, I. (2002). Non-lethal end-points in inhalation toxicology. Toxicol. Lett. 135(1): 53.
89. Ingram, R.H., Wellman, J.J., McFadden, E.R. Jr., and Mead, J. (1977). Relative contributions of large and small airways to flow limitation in normal subjects before and after atropine and isoproterenol. J. Clin. Invest. 59: 696-703.
90. Irish, D.D. and Adams, E.M. (1940). Apparatus and methods for testing the toxicity of vapors. Ind. Med. Surg. 1: 1-4.
91. Johnson, H.G., McNee, M.L., and Braughler, J.M. (1987). Inhibitors of metal catalyzed lipid peroxidation reactions inhibit mucus secretion and 15 HETE levels in canine trachea. Prostaglandins Leukot. Med. 30: 123-132.
92. 4 and dimethylphenylpiperazinium-induced responses in canine airway tracheal muscle contraction and fluid secretion. Int. Arch. Allergy Appl. Immun. 71: 214-218.
93. Kannisto, S., Voutilainen, R., Remes, K., and Korppi, M. (2002). Efficacy and safety of inhaled steroid and cromane treatment in school-age children: A randomized pragmatic pilot study. Pediatr. Allergy Immunol. 13: 24-34.
94. Karol, M.H. (1988). Immunologic responses of the lung to inhaled toxicants. In: Concepts in Inhalation Toxicology (R.O. McClellan and R. Henderson, eds.). Hemisphere Publishing, Washington, DC, pp. 403-413.
95. Karol, M.H., Hillebrand, J.A., and Thorne, P.S. (1989). Characteristics of weekly pulmonary hypersensitivity responses elicited in the guinea pig by inhalation of ovalbumin aerosols. In: Toxicology of the Lung (D.E. Gardner, J.D. Crapo, and E.J. Massaro, eds.). Raven Press, New York, pp. 427-448.
96. Kavet, R.I., Brain, J.D., and Levens, D.J. (1978). Characteristics of weekly pulmonary macrophages lavaged from hamsters exposed to iron oxide aerosols. Lab. Invest. 38: 312-319.
97. Keats, A.S. (1985). The effects of drugs on respiration in man. Ann. Rev. Pharmacol. Toxicol. 25: 41-65.
98. King, T.K.C. (1966). Measurement of functional residual capacity in the rat. J. Appl. Physiol. 21: 233-236.
99. Lalej-Bennis, D. (2001). Six month administration of gelified intranasal insulin in 16 type 1 diabetic patients under multiple injections: Efficacy vs subcutaneous injections and local tolerance. Diabetes Metab. 27(3): 372-377.
100. Landy, T.D., Ramsey, J.C., and McKenna, M.J. (1983). Pulmonary physiology and inhalation dosimetry in rats: Development of a method and two examples. Toxicol. Appl. Pharmacol. 71: 72-83.
101. Last, J.A. (1982). Mucus production and ciliary escalator. In: Mechanisms in Respiratory Toxicology, Vol. 1 (H. Witschi and P. Nettesheim, eds.). CRC Press, Boca Raton, FL, pp. 247-268.
102. Lauweryns, J.M. and Baert, J.H. (1977). Alveolar clearance and the role of the pulmonary lymphatics. Am. Rev. Resp. Dis. 115: 625-683.
103. Lawrence, S. (2002). Intranasal delivery could be used to administer drugs directly to the brain. Lancet 359: 1674.
104. Lee, W.C. and Wang, C.S. (1977). Particle deposition in systems of repeated bifurcating tubes. In: Inhaled Particles IV (W.H. Walton, ed.). Pergamon, Oxford, U.K., pp. 49-60.
105. Leigh, D.E. and Mead, J. (1974). Principles of Body Plethysmography. National Heart and Lung Institute, NIH, Bethesda, MD.
106. Leong, B.K.J. and MacFarland, H.N. (1965). Pulmonary dynamics and retention of toxic gases. Arch. Environ. Health 11: 555-563.
107. Leong, B.K.J. and Rop, D.A. (1989). The combined effects of an inhalation anesthetic and an analgesic on the electrocardiograms of beagle dogs. Abstract-475. International Congress of Toxicology. Taylor & Francis, London, U.K., p. 159.
108. Leong, B.K.J., Coombs, J.K., Petzold, E.N., and Hanchar, A.J. (1988). A dosimetric endotracheal nebulization technique for pulmonary metabolic disposition studies in laboratory animals. Inhal. Toxicol. Premier issue: 37-51.
109. Leong, B.K.J., Coombs, J.K., Petzold, E.N., Hanchar, A.H., and McNee, M.L. (1985). Endotracheal nebulization of drugs into the lungs of anesthetized animals. Toxicologist 5: 31 (abstract).
110. Leong, B.K.J., Lund, J.E., Groehn, J.A., Coombs, J.K., Sabaitis, C.P., Weaver, R.J., and Griffin, L. (1987). Retinopathy from inhaling 4,4′-methylenedianiline aerosols. Fundam. Appl. Toxicol. 9: 645-658.
111. Leong, B.K.J., Powell, D.J., and Pochyla, G.L. (1981). A new dust generator for inhalation toxicological studies. In: Inhalation Toxicology and Technology (B.K.J. Leong, ed.). Ann Arbor Science, Ann Arbor, MI, pp. 157-168.
112. Lichtiger, M., Landa, J.F., and Hirsch, J.A. (1975). Velocity of tracheal mucus in anesthetized women undergoing gynaecologic surgery. Anesthesiology 42: 753-756.
113. Lippmann, M. (1970). “Respirable” dust sampling. Am. Ind. Hyg. Assoc. J. 31: 138-159.
114. Lippmann, M. (1977). Regional deposition of particles in the human respiratory tract. In: Handbook of Physiology, Section 9, pp. 213-232.
115. Lippmann, M., Yeates, D.B., and Albert, R.E. (1980). Deposition, retention and clearance of inhaled particles. Br. J. Ind. Med. 37: 337-362.
116. Logemaan, C.D. and Rankin, L.M. (2000). Newer intranasal migraine medications. Am. Fam. Physician 61: 180-186.
117. Lourenco, R.V. and Cotromanes, E. (1982). Clinical aerosols. II. Therapeutic aerosols. Arch. Intern. Med. 142: 2299-2308.
118. MacFarland, H.N. (1976). Respiratory toxicology. In: Essays in Toxicology, Vol. 7 (W.J. Hayes, ed.). Academic Press, New York, pp. 121-154.
119. Marple, V.A. and Rubow, K.L. (1980). Aerosol generation concepts and parameters. In: Generation of Aerosols and Facilities for Exposure Experiments (K. Willeke, ed.). Ann Arbor Science, Ann Arbor, MI, p. 6.
120. Mauderly, J.L. (1974). The influence of sex and age on the pulmonary function of the beagle dog. J. Gerontol. 29: 282-289.
121. Mauderly, J.L. (1989). Effects of inhaled toxicants on pulmonary function. In: Concepts in Inhalation Toxicology (R.O. McClellan and R.F. Henderson, eds.). Hemisphere Publishing Corp, New York, pp. 347-401.
122. McClellan, R.O. and Henderson, R.F. (1989). Concepts in Inhalation Toxicology. Hemisphere, Washington, DC.
123. McFadden, E.R., Jr. (1986). Inhaled Aerosol Bronchodilators. Williams & Wilkins, Baltimore, MD, pp. 40-41.
124. McNeill, R.S. (1964). Effect of a β-adrenergic blocking agent, propranol, on asthmatics. Lancet 21: 1101-1102.
125. Menon, M.P.S. and Das, A.K. (1977). Tetracycline asthma-A case report. Clin. Allergy 7: 285-290.
126. Menzel, D.B. and Amdur, M.O. (1986). Toxic responses of the respiratory system. In: Casarett and Doull’s Toxicology, 3rd edn. (C.D. Klaassen, M.O. Amdur, and J. Doull, eds.). Macmillan, New York, pp. 330-358.
127. Mercer, T.T. (1981). Production of therapeutic aerosols; principles and techniques. Chest 80(Suppl. 6): 813-818.
128. Merlin, R.G. (1981). Cardiac toxicity of inhalation anesthetics. In: Cardiac Toxicology, Vol. II. CRC Press, Boca Raton, FL, pp. 4-10.
129. Milic-Emili, J. (1982). Recent advances in clinical assessment of control of breathing. Lung 160: 1-17.
130. Miller, F.J., Gardner, D.E., Graham, J.A., Lee, R.E., Jr., Wilson, W.E., and Bachmann, J.D. (1979). Size considerations for establishing a standard for inhalable particles. J. Air Pollut. Cont. Assoc. 29: 610-615.
131. Miller, J.L., Stuart, B.O., Deford, H.S., and Moss, O.R. (1981). Liquid aerosol generation for inhalation toxicology studies. In: Inhalation Toxicology and Technology (B.K.J. Leong, ed.). Ann Arbor Science, Ann Arbor, MI, pp. 121-207.
132. Moren, F. (1981). Pressurized aerosols for oral inhalation. Int. J. Pharm. 8: 1-10.
133. Moren, F. (1993). Aerosol dosage forms and formulations. In: Aerosols in Medicine, 2nd edn. (S. Moren, M.B. Dolovich, M.T. Newhouse, and S.P. Newman, eds.). Elsevier, Amsterdam, the Netherlands, pp. 329-336.
134. Morris, J.B. and Shusterman, D.J. (2010) Toxicology of the Nose and Upper Airway. Informa, New York.
135. Mueller, R.A. (1982). The neuropharmacology of respiratory control. Pharmacol. Rev. 34: 255-285.
136. Murphy, D.J. (1994) Safety pharmacology of the respiratory system: Techniques and study design. Drug Dev. Res. 32: 237-246.
137. 2 tension during ventilatory measurements in conscious rats. Toxicol. Methods 4: 177-187.
138. Mussatto, D.J., Garrad, C.S., and Lourenco, R.V. (1988). The effect of inhaled histamine on human tracheal mucus velocity and bronchial mucociliary clearance. Am. Rev. Respir. Dis. 138: 775-779.
139. National Academy of Sciences (NAS). (1958). Handbook of Respiration. NAS National Research Council/W.B. Saunders, Philadelphia, PA, p. 41.
140. Newman, S.P. (1984). Therapeutic aerosols. In: Aerosols and the Lung, Clinical and Experimental Aspects (S.W. Clarke and D. Pavia, eds.). Butterworth & Company, London, U.K., pp. 197-224.
141. Newton, P.E. (2000). Techniques for evaluating hazards of inhaled products. In: Product Safety Evaluation Handbook, 2nd edn. Marcel Dekker, Inc., New York, pp. 243-298.
142. Nuzzo, P.F. and Anton, W.R. (1986). Practical applications of capnography. Respir. Ther. 16: 12-17.
143. Oberst, F.W. (1961). Factors affecting inhalation and retention of toxic vapours. In: Inhaled Particles and Vapours (C.N. Davis, ed.). Pergamon Press, New York, pp. 249-266.
144. O’Neil, J.J. and Raub, J.A. (1984). Pulmonary function testing in small laboratory mammals. Environ. Health Perspect. 53: 11-22.
145. O’Neil, M.J. (2006). The Merck Index, 14th edn. Merck & Co., Inc., Whitehouse Station, NJ.
146. Palecek, F. (1969). Measurement of ventilatory mechanics in the rat. J. Appl. Physiol. 27: 149-156.
147. Parent, R.A. (1991). Comparative Biology of the Normal Lung. CRC Press, Boca Raton, FL.
148. Paterson, J.W. (1977). Bronchodilators. In: Asthma (T.J.H. Clark and S. Godfrey, eds.). Chapman and Hall, London, U.K., pp. 251-271.
149. Paterson, J.W., Woocock, A.J., and Shenfield, G.M. (1979). Bronchodilator drugs. Am. Rev. Respir. Dis. 120: 1149-1188.
150. Patterson, R. and J.F. Kelly. (1974). Animal models of the asthmatic state. Ann. Rev. Med. 25: 53-68.
151. Patty, F.A. (1958). Industrial Hygiene and Toxicology, 2nd edn. Interscience, New York.
152. Pauluhn, J. (2002). Overview of testing methods used in inhalation toxicology: From facts to artifacts. Eurotox 2002, Budapest, Hungary, pp. 5-7.
153. Paustenbach, D.J., Carlson, G.P., Christian, J.E., Born, G.S., and Rausch, J.E. (1983). A dynamic closed-loop recirculating inhalation chamber for conducting pharmacokinetic and short-term toxicity studies. Fundam. Appl. Toxicol. 3: 528-532.
154. Pavia, D. (1984). Lung mucociliary clearance. In: Aerosols and the Lung, Clinical and Experimental Aspects (S.W. Clarke and D. Pavia, eds.). Butterworth & Co, London, U.K., pp. 127-155.
155. Pavia, D., Bateman, J.R.M., Sheahan, N.F., Agnew, J.E., Newman, S.P., and Clarke, S.W. (1980). Techniques for measuring lung mucociliary clearance. Eur. J. Respir. Dis. 67(Suppl. 110): 157-177.
156. Pavia, D., Sutton, P.P., Agnew, J.E., Lopez-Vidriero, M.T., Newman, S.P., and Clarke, S.W. (1983a). Measurement of bronchial mucociliary clearance. Eur. J. Respir. Dis. 64(Suppl. 127): 41-56.
157. Pavia, D., Sutton, P.P., Lopez-Vidriero, M.T., Agnew, J.E., and Clarke, S.W. (1983b). Drug effects on mucociliary function. Eur. J. Respir. Dis. 64(Suppl. 128): 304-317.
158. Phalen, R.F. (2009). Inhalation Studies: Foundations and Techniques, 2nd edn. Informa, Boca Raton, FL, pp. 35-46, 51-57.
159. Pigott, G.H. (2009) Inhalation toxicology. In: General and Applied Toxicology, 3rd edn. (B. Ballantyne, T.C. Marrs, and T. Syversen, eds.). Wiley, Hoboken, NJ.
160. Rinehart, W.E. and Hatch, T. (1964). Concentration-time product (Ct) as an expression of dose in sublethal exposures to phosgene. Am. Ind. Hyg. Assoc. J. 25: 545-553.
161. Rosnow, E.C. (1992). Drug-induced pulmonary disease: An update. Chest 102: 239-250.
162. Rylander, R. (1966). Current techniques to measure alterations in the ciliary activity of intact respiratory epithelium. Am. Rev. Respir. Dis. 93(Suppl.): 67-85.
163. Sackner, M.A., Brown, L.K., and Kim, C.S. (1981). Basis of an improved metered aerosol delivery system. Chest 80(Suppl. 6): 915-918.
164. Salem, H. and Katy, S.A. (2006). Inhalation Toxicology, 2nd edn. Tayler & Francis, Philadelphia, PA.
165. Schreck, R.W., Sekuterski, J.J., and Gross, K.B. (1986). Synchronized intratracheal aerosol generation for rodent studies. In: Aerosols, Formation and Reactivity, Second International Aerosol Conference, Berlin, Germany. Pergamon Press, New York, pp. 37-51.
166. Schwettmann, R.S. and Casterline, C.L. (1976). Delayed asthmatic response following occupational exposure to enflurane. Anesthesiology 44: 166-169.
167. Shao, Z., Krishnamoorthy, R., and Mitra, A.K. (1992). Cyclodextrins as nasal absorption promoters of insulin-mechanistic evaluations. Pharm. Res. 9(9): 1157-1163.
168. Shao, Z. and Mitra, A.K. (1992). Nasal membrane and intracellular protein and enzyme release by bile salts and bile salt fatty-acid mixed micelles-correlation with facilitated drug transport. Pharm. Res. 9: 1184-1189.
169. Sharma, S., White, G., Imondi, A.R., Plaelse, M.E., Vail, D.M., and Dris, M.G. (2001). Development of inhalation agents for oncological use. J. Clin. Oncol. 19: 1839-1847.
170. Sidorenko, G.I. and Pinigin, M.A. (1976). Concentration-time relationship for various regimens of inhalation of organic compounds. Environ. Health Perspect. 13: 17-21.
171. Silver, S.D. (1946). Constant flow gassing chambers: Principles influencing design and operation. J. Lab. Clin. Med. 31: 1153-1161.
172. Sinnet, E.E. (1981). Fast integrated flow plethysmograph for small mammals. J. Appl. Physiol. 50: 1104-1110.
173. Smaldone, G.C. (1997). Determinants of dose and response to inhaled therapeutic agents in asthma. In: Inhaled Glucocorticoids in Asthma: Mechanisms and Clinical Actions (R.P. Schleimer, W.W. Busse, and P.M. O’Byrne, eds.). Marcel Dekker, New York, pp. 447-477.
174. Stahlhofen, W., Gebhart, J., and Heyder, J. (1980). Experimental determination of the regional deposition of aerosol particles in the human respiratory tract. Am. Ind. Hyg. Assoc. J. 41: 385-398.
175. Stahlhofen, W., Gebhart, J., and Heyder, J. (1981). Biological variability of regional deposition of aerosol particles in the human respiratory tract. Am. Ind. Hyg. Assoc. J. 42: 348-352.
176. Stott, W.T. and McKenna, M.J. (1984). The comparative absorption and excretion of chemical vapors by the upper, lower and intact respiratory tract of rats. Fundam. Appl. Toxicol. 4: 594-602.
177. Swift, D.B. and Proctor, D.F. (1982). Human respiratory deposition of particles during oronasal breathing. Atmos. Environ. 16: 2279-2282.
178. Tamulinas, C.B. and Leach, C.L. (2000). Routes of exposure: Inhalation and intranasal. In: Excipient Toxicology and Safety (M.L. Weiner and L.A. Kotkoskie, eds.). Marcel Dekker, New York, pp. 185-205.
179. Task Group on Lung Dynamics. (1966). Deposition and retention models for internal dosimetry of the human respiratory tract. Health Phys. 12: 173-207.
180. Tattersfield, A.E. (1986). Beta adrenoreceptor antagonists and respiratory disease. J. Cardiovasc. Pharmacol. 8(Suppl. 4): 535-539.
181. Taulbee, D.B., Yu, C.P., and Heyder, J. (1978). Aerosol transport in the human lung from analysis of single breaths. J. Appl. Physiol. 44: 803-812.
182. Thorne, P.S. and Karol, M.H. (1989). Association of fever with late-onset pulmonary hypersensitivity responses in the guinea pig. Toxicol. Appl. Pharmacol. 100: 247-258.
183. Touvay, C. and Le Mosquet, B. (2000). Systeme respiratoire et pharmacology de securite. Therapie 55: 71-83.
184. Ts’o, T.O.T., Leong, B.K.J., and Chenoweth, M.B. (1975). Utilities and limitations of behavioral techniques in industrial toxicology. In: Behavioral Toxicology (B. Weiss and V.G. Laties, eds.). Plenum Press, New York, pp. 265-291.
185. Uemitsu, N., Minobe, Y., and Nakayoshi, H. (1985). Concentration-time-response relationship under conditions of single inhalation of carbon tetrachloride. Toxicol. Appl. Pharmacol. 77: 260-266.
186. Ugwoke, M.I., Verbeke, N., and Kinget, R. (2001). The biopharmaceutical aspects of nasal mucoadhesive drug delivery. J. Pharm. Pharmacol. 53: 3-21.
187. Ulrich, C.E., Klonne, D.R., and Church, S.V. (1984). Automated exposure system for metered-dose aerosol pharmaceuticals. Toxicologist 4: 48.
188. Valentine, R. and Kennedy, G.L., Jr. (2001). Inhalation toxicology. In: Principles and Methods of Toxicology, 4th edn. (W. Hayes, ed.). Raven Press, New York, pp. 1085-1143.
189. 99 Tc-labeled drug particles administered via a dry powder inhaler. Int. J. Pharm. 39: 101-105.
190. Wanner, A. (1979). The role of mucociliary dysfunction in bronchial asthma. Am. J. Med. 67: 477-485.
191. Wanner, A. (1981). Alteration of tracheal mucociliary transport in airway disease. Effect of pharmacologic agents. Chest 80(Suppl. 6): 867-870.
192. Webber, S.E. and Widdicombe, J.G. (1987). The actions of methacholine, phenylephrine, salbutamol and histamine on mucus secretion from the ferret in-vitro trachea. Agents Actions 22: 82-85.
193. Weibel, E.R. (1963). Morphometry of the Human Lung. Springer-Verlag, Heidelberg, Germany.
194. Weibel, E.R. (1983). How does lung structure affect gas exchange? Chest 83: 657-665.
195. Westfall, T.C. and Westfall, D.P. (2011) Adrenergic agonists and antagonists. In: Goodman & Gilman’s: The Pharmacological Basis of Therapeutics, 12th edn. (B.L. Brunton, B. Chabner, and B. Knollman, eds.). McGraw Hill Medical, New York, pp. 277-304.
196. Weston, R. and Karel, L. (1946). An application of the dosimetric method for biologically assaying inhaled substances. J. Pharmacol. Exp. Ther. 88: 195-207.
197. Widdicombe, J.G. (1974). Reflex control of breathing. In: Respiratory Physiology, Vol. 2 (J.G. Widdicombe, ed.). University Park Press, Baltimore, MD.
198. Willeke, K. (1980). Generation of Aerosols and Facilities for Exposure Experiments. Ann Arbor Science, Ann Arbor, MI.
199. Williams, M.H. (1974). Steroids and antibiotic aerosols. Am. Rev. Respir. Dis. 110: 122-127.
200. Wills, P. and Greenstone, M. (2001). Inhaled hyperosmolar agents for bronchiectasis. Cochrane Database Syst. Rev. CD002996.
201. Wilson, A.G.E. (1982). Toxicokinetics of uptake, accumulation, and metabolism of chemicals by the lung. In: Mechanisms in Respiratory Toxicology, Vol. 1 (H. Witschi and P. Nettesheim, eds.). CRC Press, Boca Raton, FL, pp. 162-178.
202. Witschi, H.P. and Brain, J.D. (1985). Toxicology of Inhaled Materials. Springer-Verlag, New York.
203. Witschi, H.P. and Nettesheim, P. (1982). Mechanisms in Respiratory Toxicology, Vol. 1. CRC Press, Boca Raton, FL.
204. Zhang, Y. and Jiang, X. (2001). Detoxification of nasal toxicity of nasal drug delivery system. Zhongguo Yiyao Gongye Zazhi 32: 323-327.