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Halcion [[electronic resource] ] : an independent assessment of safety and efficacy data / / Committee on Halcion: An Assessment of Data Adequacy and Confidence, Division of Health Sciences Policy, Division of Neuroscience and Behavioral Health, Institute of Medicine
| Halcion [[electronic resource] ] : an independent assessment of safety and efficacy data / / Committee on Halcion: An Assessment of Data Adequacy and Confidence, Division of Health Sciences Policy, Division of Neuroscience and Behavioral Health, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1997 |
| Descrizione fisica | 1 online resource (176 p.) |
| Disciplina | 615/.782 |
| Soggetto topico |
Triazolam
Tranquilizing drugs |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-18720-4
9786610187201 0-309-59145-7 0-585-15632-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910455690003321 |
| Washington, D.C., : National Academy Press, 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Halcion [[electronic resource] ] : an independent assessment of safety and efficacy data / / Committee on Halcion: An Assessment of Data Adequacy and Confidence, Division of Health Sciences Policy, Division of Neuroscience and Behavioral Health, Institute of Medicine
| Halcion [[electronic resource] ] : an independent assessment of safety and efficacy data / / Committee on Halcion: An Assessment of Data Adequacy and Confidence, Division of Health Sciences Policy, Division of Neuroscience and Behavioral Health, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1997 |
| Descrizione fisica | 1 online resource (176 p.) |
| Disciplina | 615/.782 |
| Soggetto topico |
Triazolam
Tranquilizing drugs |
| ISBN |
0-309-17444-9
1-280-18720-4 9786610187201 0-309-59145-7 0-585-15632-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778776703321 |
| Washington, D.C., : National Academy Press, 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Halcion : an independent assessment of safety and efficacy data / / Committee on Halcion: An Assessment of Data Adequacy and Confidence, Division of Health Sciences Policy, Division of Neuroscience and Behavioral Health, Institute of Medicine
| Halcion : an independent assessment of safety and efficacy data / / Committee on Halcion: An Assessment of Data Adequacy and Confidence, Division of Health Sciences Policy, Division of Neuroscience and Behavioral Health, Institute of Medicine |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1997 |
| Descrizione fisica | 1 online resource (176 p.) |
| Disciplina | 615/.782 |
| Soggetto topico |
Triazolam
Tranquilizing drugs |
| ISBN |
0-309-17444-9
1-280-18720-4 9786610187201 0-309-59145-7 0-585-15632-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 REPORT -- 2 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 Literature -- CONCLUSIONS 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 Coordination -- Confusion -- 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 STUDY -- SPONTANEOUS 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 -- Performance of Memory Tasks After Single and Multiple Doses -- Spontaneous Reports of Memory Impairment -- Halcion and State-Dependent Learning -- Summary -- Review of Data Regarding Possible Anxiogenic or Insomniac Effects Associated with Halcion Administration or Withdrawal -- Halcion Effects on Daytime Anxiety -- Withdrawal-Related Anxiety or Insomnia Following Short- and Long-Term Halcion Use -- Rebound Anxiety -- Rebound Insomnia -- Summary -- Ataxia, Disinhibition, and Psychotogenic, Confusional, or Dissociative Effects of Halcion -- Consideration of Other Potential Adverse Effects -- Early Termination of Use -- Adverse Effects Defined Generally -- Other Adverse Effects -- Summaries and Meta-Analyses -- Closing Comments -- CONCLUSIONS AND RECOMMENDATIONS -- Clinical Trials and Surveillance -- 4 Additional Comments on Broader Implications -- References -- A FDA Safety Tables -- B Summary Tables of Literature Reviewed for Safety of Halcion. C Glossary -- D Acronyms -- E Resources Reviewed by the Committee -- F Consent to Disclosure -- CONSENT TO DISCLOSURE -- G Committee and Staff Biographies -- COMMITTEE -- IOM STAFF. |
| Record Nr. | UNINA-9910825955103321 |
| Washington, D.C., : National Academy Press, 1997 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Sedation : a guide to patient management / / Stanley F. Malamed, DDS, Emeritus Professor of Anesthesia and Medicine, School of Dentistry, University of Southern California, Los Angeles, California
| Sedation : a guide to patient management / / Stanley F. Malamed, DDS, Emeritus Professor of Anesthesia and Medicine, School of Dentistry, University of Southern California, Los Angeles, California |
| Autore | Malamed Stanley F. <1944-> |
| Edizione | [Sixth edition.] |
| Pubbl/distr/stampa | St. Louis, Missouri : , : Elsevier, , [2018] |
| Descrizione fisica | 1 online resource (xi, 620 pages) : illustrations |
| Disciplina | 615/.782 |
| Soggetto topico | Anesthesia in dentistry |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910583452403321 |
Malamed Stanley F. <1944->
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| St. Louis, Missouri : , : Elsevier, , [2018] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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