Table of Contents
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3. Graham, D. Y., "Enzyme Replacement Therapy of Exocrine Pancreatic Insufficiency in Man: Relation Between In Vitro Enzyme Activities and In Vivo Potency in Commercial Pancreatic Extracts, 'I New England Journal of Medicine, 296:1314-1317, 1977.
4. Fatmi, A. A., and J. A. Johnson, "An In Vitro Comparative Evaluation of Pancreatic Enzyme Preparations, m Drug Development and Industrial Pharmacy, 14:1429-1438, 1988.
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6. Mischler, E. H. et al., "Comparison of Effectiveness of Pancreatic Enzyme Preparations in Cystic Fibrosis," American Journal of Diseases of Children, 136:1060-1063, 1982.
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S. K., V. S. Hubbard, and M. Appler, "Critical Examination of Therapeutic
Efficacy of a pH-Sensitive Enteric-Coated Pancreatic Enzyme Preparation in Treatment
of Exocrine Pancreatic Insufficiency Secondary to
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9. Beverley, D. W. et al., "Comparison of Four Pancreatic Extracts in Cystic Fibrosis," Archives of Disease in Childhood, 62:564-568, 1987.
10. Cystic Fibrosis Foundation Results of a Survey of 114 Cystic Fibrosis Care Centers in United States, Patient Registry 1992 Annual Data Report, Bethesda, MD, October 1993, in OTC Vol. 17BFR, Docket No. 79N-0379, Dockets Management Branch.
11. Smyth, R. L. et al., "Strictures of Ascending Colon in Cystic Fibrosis and High-Strength Pancreatic Enzymes," Lancet, 343:85-86, 1994.
12. Oades, P. J. et al., "Letter to the Editor," Lancet, 343:109, 1994.
13. Campbell, C. A., J. Forrest, and C. Musgrove,' "Letter to the Editor," Lancet, 343:109, 1994.
14. Briars, G. L. et al., "Letter to the Editor," Lancet, 343:600, 1994.
15. Mahony, M. J. and M. Corcoran, "Letter to the Editor," Lancet, 343:599-600, 1994.
16. Knabe, N. et al., "Letter to the Editor," Lancet, 343:1230, 1994.
17. Taylor, C. J. "Colonic Strictures in Cystic Fibrosis," Lancet, 343:615-616, 1994.
18. Letter dated February 14, 2001, from P. W. Campbell, III, Cystic Fibrosis Foundation, to L. Talarico, FDA.