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Review of the Fialuridine (FIAU) Clinical Trials (1995)
Institute of Medicine (IOM)

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. "Appendix B: Bibliography and References." Review of the Fialuridine (FIAU) Clinical Trials. Washington, DC: The National Academies Press, 1995.

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Review of the Fialuridine (FIAU) Clinical Trials

Capalbo, M.; Actis, C.; Maurizia, R.; Brunetto, R.; Poli, G.; Baldi, M.; Palmisano, L.; Verme, G.; Bonino, F. 1992. Treatment of chronic hepatitis B with beta interferon given intramuscularly: A pilot study. Italian Journal of Gastroenterology; 24: 203-205.

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Page
166
Front Matter (R1-R10)
Executive Summary (1-15)
Introduction (16-19)
Clinical Trials (20-33)
Hepatitis B and Other Viral Diseases (34-41)
Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center (42-50)
Oclassen Clinical Trial R89-001-01 (51-54)
Oclassen Clinical Trial R90-001-01 (NIH Protocol 91-AI-0031) (55-60)
Oclassen Clinical Trial R91-001-10 (NIH Protocol 91-DK-AI-213) (61-65)
Eli Lilly Trial H3X-MC-PPPA (66-69)
Eli Lilly Trial H3X-MC-PPPG (70-72)
Eli Lilly Trial H3X-MC-PPPC (NIH Protocol 93-DK-0031) (73-89)
Summary of Patient Interviews (90-92)
Overall Assessment of the Trials (93-97)
Recent Studies of FIAU Toxicity (98-103)
Review of the FDA Task Force Report 'Fialuridine: Hepatic and Pancreatic Toxicity' (104-120)
Review of 'Report to the Advisory Committee to the Director, National Institutes of Health' (121-132)
FDA-Proposed Changes to the Code of Federal Regulations (133-142)
Ancillary Issues Raised During the Period Following The H3X-MC-PPPC Trial (143-149)
Conclusions and Recommendations (150-154)
Appendix A: Chronology of FIAU/FIAC Clinical Trials (155-164)
Appendix B: Bibliography and References (165-177)
Appendix C: Agendas from the Three Committee Meetings (178-183)
Appendix D: Informed Consent Documents (184-243)
Appendix E: Example of Oclassen Fax Data Summaries (244-245)
Appendix F: FIAC and FIAU Preclinical Toxicity Studies (246-250)
Appendix G: Patient Summaries, Lilly Trial H3X-MC-PPPA (251-255)
Appendix H: Statistical Analysis of Mortality in the FIAU/FIAC Clinical Trials (256-265)
Glossary (266-269)