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Rational Therapeutics for Infants and Children: Workshop Summary References Agertoft, L., and S. Pedersen. 1994. Effects of long-term treatment with an inhaled corticosteroid on growth and pulmonary function in asthmatic children. Respiratory Medicine 88:373–381. American Academy of Pediatrics, Committee on Drugs. 1977. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 60:91–101. American Academy of Pediatrics, Committee on Drugs. 1995. Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations (RE9503). Pediatrics 95(2):286–294. Andersson, K. E., A. Bertler, and G. Wettrell. 1975. Post-mortem distribution and tissue concentrations of digoxin in infants and adults. Acta Paediatrica Scandinavica 64(3):497–504. Aranda, J. V., J. M. Collinge, R. Zinman, and G. Watters. 1979. Maturation of caffeine elimination in infancy. Archives of Disease in Children 54:946–949. Bajpai, M., L. K. Roskos, D. D. Shen, and R. H. Levy. 1996. Roles of cytochrome P4502C9 and cytochrome P4502C19 in the stereoselective metabolism of phenytoin to its major metabolite. Drug Metabolism and Disposition 24:1401–1403. Bartholome, W. G. 1977. The ethics of non-therapeutic clinical research on children. In Appendix to Report and Recommendations: Research Involving Children. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. DHEW Publication No. (OS) 77-0005:3–17. Bartholome, W. G. 1996. Ethical issues in pediatric research. In The Ethics of Research Involving Human Subjects. Edited by Harold Y. Vanderpool. Frederick, Md.: University Publishing Group. 356, 360–361. Bourgeois, B. F. D., and W. E. Dodson. 1983. Phenytoin elimination in newborns . Neurology 33:173–178.

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Rational Therapeutics for Infants and Children: Workshop Summary DuBuske, L. M., J. Grossman, and L. M. Dube. 1997. Randomized trial in patients with moderate asthma: Effect of reduced dosing frequency and amounts on pulmonary function and asthma symptoms. American Journal of Managed Care 3:633–640. Ellenberg, S. S., N. Geller, R. Simon, and S. Yusuf (eds). 1993. Proceedings of "Practical Issues in Data Monitoring of Clinical Trials." Statistics in Medicine 12:415–616. FDA (U.S. Food and Drug Administration). 1992. New drug antibiotic and biological drug product regulations: Accelerated approval. Proposed Rule 57 Federal Register. FDA. 1996. Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance. Bethesda, Md.: Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. April 1996. FDA. 1997a. Food and Drug Administration Modernization Act of 1997. Section III. The pediatric exclusivity provision. FDA. 1997b. Good clinical practice: Consolidated guidance (FDA guidance document). Federal Register 62:25691–25709. FDA. 1998a. Pulmonary and Allergy and Endocrinology Advisory Committees Meeting. Bethesda, Md.: U.S. Food and Drug Administration. July 30–31, 1998. FDA. 1998b. Draft Guidance: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products. Bethesda, Md.: U.S. Food and Drug Administration. November 10, 1998. FDA. 1998c. Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products. Bethesda, Md.: Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. November, 1998. FDA. 1998d. Statistical principles for clinical trials (FDA guidance document). Federal Register 63: 49583–49598. FDA. 1998e. Regulations requiting manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. 63 Federal Register 66632–66672. (codified at 21CFR Parts 201, 312, 314 and 601). FDA. 1999. Guidance for Industry: Population Pharmacokinetics. Bethesda, Md.: Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. February 1999. Fleming, T. R. and D. L. DeMets. 1993. Monitoring of clinical trials: Issues and recommendations. Controlled Clinical Trials 14(3): 183–197. Forrest, A., D. E. Nix, C. H. Ballow, T. F. Goss, M. C. Birmingham, and J. J. Sehentag. 1993. Pharmacodynamics of intravenous ciprofloxacin in seriously ill patients. Antimicrobial Agents and Chemotherapy 37:1073–1081. Freedman, B. 1987. Equipoise and the ethics of clinical research. New England Journal of Medicine 317(3):141–145. Fritz, S., W. Lindner, I. Roots, B. M. Frey, and A. Küpfer. 1987. Stereochemistry of aromatic phenytoin hydroxylation in various drug hydroxylation phenotypes in humans. Journal of Pharmacology and Experimental Therapies 241:615–622. Garbe, E., J. LeLorier, J.F. Boivin, and S. Suissa. 1997. Inhaled and nasal glucocorticoids and the risks of ocular hypertension or open-angle glaucoma. Journal of the American Medical Association 277:722–727. Garbe, E., S. Suissa, and J. LeLorier. 1998. Association of inhaled corticosteroid use with cataract extraction in elderly patients. Journal of the American Medical Association 280:539–543.

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