Halcion : an Independent Assessment of Safety and Efficacy Data.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Staff, Institute of Medicine
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, 1997.
Temas:
Triazolam.
Tranquilizing drugs.
Triazolam
Tranquilizing drugs
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Halcion
  • Copyright
  • Acknowledgments
  • Preface
  • Contents
  • Executive Summary
  • THE DATA
  • ASSESSMENT OF EFFICACY DATA
  • Conclusions and Recommendations
  • Data Adequacy
  • Clinical Trial Design
  • Tolerance
  • ASSESSMENT OF SAFETY DATA
  • Conclusions and Recommendations
  • Clinical Trials and Surveillance
  • BROADER IMPLICATIONS
  • 1 Introduction
  • HISTORICAL OVERVIEW OF HALCION
  • Overseas Events
  • FDA Activity
  • Spontaneous Reports
  • FDA Reassessment
  • FDA Task Force
  • CHARGE TO THE IOM COMMITTEE
  • ORGANIZATION OF THE REPORT2 Assessment of Efficacy Data
  • PURPOSE AND EVALUATION OF HYPNOTIC DRUGS
  • Evaluating Efficacy
  • FDA Efficacy Requirements
  • Available Efficacy Data on Halcion
  • QUALITY OF PROTOCOLS AND STUDY DESIGN
  • Study Design
  • Endpoints
  • Polysomnographic Studies
  • REVIEW OF STATISTICAL METHODS USED BY UPJOHN AND FDA TO EVALUATE EFFICACY DATA
  • Statistical Reanalysis and Evaluation of Clinical Trial Efficacy Data
  • Random-Effect Regression Models
  • Results of Reanalysis
  • Dose Response
  • LITERATURE REVIEW
  • Polysomnographic Studies of Halcion in the Published LiteratureCONCLUSIONS AND RECOMMENDATIONS
  • Data Adequacy
  • Clinical Trial Design
  • Tolerance
  • 3 Assessment of Safety Data
  • WELL-CONTROLLED PREMARKETING CLINICAL TRIALS
  • Adverse Events
  • Integrated Summary of Safety
  • Observation 1: Comparable Safety Profile
  • Observation 2: Comparable Rates of CNS-Related Events
  • Observation 3: Increased Sensitivity in Geriatric Subjects
  • Summary
  • IOM Analysis of Upjohn's Integrated Summary of Safety
  • Nervousness
  • Memory Impairment
  • Impaired CoordinationConfusion
  • Summary
  • Analysis of Dropouts
  • FDA Analysis
  • IOM Analysis
  • Statistical Analysis
  • Halcion (0.5 mg) Versus Placebo in Non-geriatric Subjects
  • Halcion (0.5 mg) Versus Flurazepam (30 mg) in Non-geriatric Subjects
  • Halcion (0.25 mg) Versus Placebo in Geriatric Subjects
  • Halcion (0.25 mg) Versus Flurazepam (15 mg) in Geriatric Subjects
  • Summary
  • DATA SETS FOR POSTMARKETING STUDIES
  • Randomized Study: Protocol M/2100/0235
  • Randomized Polysomnographic Studies
  • A Nonrandomized Controlled Study: EMIC
  • VAMP: A COHORT STUDYSPONTANEOUS REPORTING OF ADVERSE EVENTS: THE FDA SYSTEM
  • Statistical Evaluation of the SRS Data
  • LITERATURE REVIEW
  • Pharmacokinetic and Pharmacodynamic Issues Regarding the Comparability of Triazolam to Other Benzodiazepines
  • Pharmacokinetic Issues
  • Affinity for Benzodiazepine Receptors
  • Lipophilicity
  • Agonist Status
  • Levels in Plasma
  • Pharmacodynamic Interactions
  • Unique Effects of Triazolobenzodiazepines on Locus Coeruleus Neurons
  • Summary
  • Consideration of Amnestic Effects of Halcion

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