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Review of the Fialuridine (FIAU) Clinical Trials.
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Washington :
National Academies Press,
1900.
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| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- ""Review of the Fialuridine (FIAU) Clinical Trials""; ""Copyright""; ""Preface""; ""Contents""; ""Executive Summary""; ""INTRODUCTION""; ""CLINICAL TRIALS""; ""HEPATITIS B AND OTHER VIRAL DISEASES""; ""EARLY CLINICAL TRIALS OF FIAC AT MEMORIAL SLOAN-KETTERING CANCER CENTER""; ""OCLASSEN CLINICAL TRIAL R89-001-01""; ""OCLASSEN CLINICAL TRIAL R90-001-01""; ""OCLASSEN CLINICAL TRIAL R-91-010""; ""ELI LILLY CLINICAL TRIAL H3X-MC-PPPA""; ""ELI LILLY TRIAL H3X-LC-PPPG""; ""ELI LILLY TRIAL H3X-MC-PPPC (NIH PROTOCOL #93-DK-0031)""; ""PATIENT INTERVIEWS""; ""OVERALL ASSESSMENT OF THE TRIALS""
- ""REVIEW OF THE FDA TASK FORCE REPORT""""REVIEW OF THE NIH REPORT""; ""FDA-PROPOSED CHANGES TO THE CODE OF FEDERAL REGULATIONS""; ""ANCILLARY ISSUES""; ""CONCLUSIONS""; ""RECOMMENDATIONS""; ""Generic Issues""; ""Trial Design""; ""Adverse Event Reporting""; ""Compliance Audits""; ""Further Research Into FIAU Toxicity""; ""1 Introduction ""; ""GENESIS OF THIS STUDY""; ""CHARGE TO THE COMMITTEE""; ""METHODS AND PROCEDURE""; ""PLAN OF THE REPORT""; ""2 Clinical Trials ""; ""IMPORTANCE OF CLINICAL TRIALS""; ""THE RISK-BENEFIT NATURE OF TRIALS""; ""THE DRUG DEVELOPMENT PROCESS""; ""SAFETY REPORTS""
- ""ETHICAL CONSIDERATIONS""""Procedural Requirements""; ""Substantive Norms""; ""A Favorable Balance of Harms and Benefits""; ""Equitable Selection of Subjects""; ""Compensation for Research-Related Injury""; ""Informed Consent""; ""SUMMARY""; ""3 Hepatitis B and Other Viral Diseases ""; ""NATURE OF CHRONIC VIRAL DISEASES""; ""NATURAL HISTORY OF CHRONIC HBV INFECTION""; ""NEED FOR ORALLY ACTIVE AGENTS""; ""THE FLARE PHENOMENON""; ""TOXIC EFFECTS OF OTHER NUCLEOSIDE ANALOGS""; ""SUMMARY""; ""4 Clinical Trials of FIAC at Memorial Sloan-Kettering Cancer Center ""
- ""PHASE I EVALUATION OF FIAC IN IMMUNOSUPPRESSED PATIENTS WITH HERPESVIRUS INFECTION""""Comment""; ""PHASE I STUDY OF AIDS PATIENTS WITH PRESUMPTIVE OR PROVEN HERPESGROUP VIRUS INFECTION""; ""Comment""; ""PHASE I STUDY OF FIAC IN BONE MARROW TRANSPLANT PATIENTS WITH HERPESGROUP VIRUS INFECTIONS""; ""Comment""; ""PHASE I ORAL DOSE RANGING FIAC STUDY IN IMMUNOCOMPROMISED PATIENTSWITH VZV AND HSV INFECTIONS""; ""Comment""; ""PHASE I/II TRIAL OF FIAC EFFICACY IN IMMUNOSUPPRESSED PATIENTS WITHVZV INFECTION""; ""Comment""; ""SUMMARY OF ALL THE FIAC CLINICAL STUDIES AT MSKC""
- ""5 Oclassen Clinical Trial R89-001-01""""COMMENT""; ""6 Oclassen Clinical Trial R90-001-01 (NIH Protocol 91-AI-0031) ""; ""COMMENT""; ""7 Oclassen Clinical Trial R91-001-10 (NIH Protocol 91-DK-AI-213) ""; ""COMMENT""; ""8 Eli Lilly Trial H3X-MC-PPPA ""; ""UNIVERSITY OF TEXAS, GALVESTON SITE""; ""TUFTS NEW ENGLAND MEDICAL CENTER SITE""; ""9 Eli Lilly Trial H3X-MC-PPPG ""; ""COMMENT""; ""10 Eli Lilly Trial H3X-MC-PPPC (NIH Protocol 93-DK-0031) ""; ""AVAILABLE CLINICAL DATA REGARDING POTENTIAL TOXICITY""; ""AVAILABLE SAFETY DATA""; ""DEVELOPMENT OF PROTOCOL AND FDA REVIEW""