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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

Young, C. W.; Schneider, R.; Leyland-Jones, B.; Armstrong, D.; Tan, C. T.; Lopez, C.; Watanabe, K. A.; Fox, J. J.; Philips, F. S. 1983. Phase 1 evaluation of 2'fluoro-5-iodo-1-beta-D-arabinofuranosylcytosine in immunosuppressed patients with herpes virus infection. Cancer Research; 43: 5006.


Zarafonetis, C. J. D.; Riley, P. A.; Willis, P. W.; Power, L. H.; Werbelow, J.; Farhat, L.; Beckwith, W.; Marks, B. H. 1978. Clinically significant adverse effects in a Phase I testing program. Clinical Pharmacology and Therapeutics; 24(2): 127-132.

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177
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)