03N-0205
BKG 1
Volume 1
Table
of Contents
1. Hendeles,
L. et al., "Treatment Failure After Substitution of Generic Pancrelipase
Capsules: Correlation with In Vitro Lipase Activity," Journal of the American
Medical Association, 263:2459-2461, 1990.
2. Regan,
P. T. et al., "Comparative Effects of Antacids, Cimetidine and Enteric
Coating on the Therapeutic Response to Oral Enzymes in Severe Pancreatic Insufficiency,"
New England Journal of Medicine, 297:854-858, 1977.
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.
5. Graham,
D. Y. "An Enteric-Coated Pancreatic Enzyme Preparation that Works,"
Digestive Diseases and Sciences, 24:906-909, 1979.
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.
7. Littlewood,
J. M. et al., "In Vivo and In Vitro Studies of Microsphere Pancreatic Supplements,
'1 Journal of Pediatric Gastroenterology and Nutrition, 7 (Supplement T):S22-S29,
1988.
8. Dutta,
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
Cystic Fibrosis," Digestive Diseases and Sciences, 33:1237-1244, 1988.
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.