|
|
|
|
| LEADER |
00000cam a2200000Mi 4500 |
| 001 |
EBOOKCENTRAL_ocn923260976 |
| 003 |
OCoLC |
| 005 |
20240329122006.0 |
| 006 |
m o d |
| 007 |
cr |n||||||||| |
| 008 |
151010s1997 dcu o 000 0 eng d |
| 040 |
|
|
|a EBLCP
|b eng
|e pn
|c EBLCP
|d OCLCQ
|d MERUC
|d OCLCQ
|d ZCU
|d ICG
|d OCLCO
|d OCLCF
|d OCLCQ
|d OCLCO
|d OCLCQ
|d DKC
|d OCLCQ
|d UKAHL
|d OCLCQ
|d OCLCO
|d OCLCQ
|d OCLCO
|
| 020 |
|
|
|a 9780309591454
|
| 020 |
|
|
|a 0309591457
|
| 029 |
1 |
|
|a DEBBG
|b BV044106864
|
| 035 |
|
|
|a (OCoLC)923260976
|
| 050 |
|
4 |
|a RM666.T784.I56 1997eb
|
| 082 |
0 |
4 |
|a 615.7
|
| 049 |
|
|
|a UAMI
|
| 100 |
1 |
|
|a Staff, Institute of Medicine.
|
| 245 |
1 |
0 |
|a Halcion :
|b an Independent Assessment of Safety and Efficacy Data.
|
| 260 |
|
|
|a Washington :
|b National Academies Press,
|c 1997.
|
| 300 |
|
|
|a 1 online resource (176 pages)
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 588 |
0 |
|
|a Print version record.
|
| 505 |
0 |
|
|a 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
|
| 505 |
8 |
|
|a 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
|
| 505 |
8 |
|
|a 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
|
| 505 |
8 |
|
|a 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
|
| 505 |
8 |
|
|a 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
|
| 500 |
|
|
|a ""Performance of Memory Tasks After Single and Multiple Doses""
|
| 590 |
|
|
|a ProQuest Ebook Central
|b Ebook Central Academic Complete
|
| 650 |
|
0 |
|a Triazolam.
|
| 650 |
|
0 |
|a Tranquilizing drugs.
|
| 650 |
|
2 |
|a Triazolam
|
| 650 |
|
6 |
|a Triazolam.
|
| 650 |
|
7 |
|a Tranquilizing drugs
|2 fast
|
| 650 |
|
7 |
|a Triazolam
|2 fast
|
| 776 |
0 |
8 |
|i Print version:
|a Staff, Institute of Medicine.
|t Halcion : An Independent Assessment of Safety and Efficacy Data.
|d Washington : National Academies Press, ©1900
|z 9780309059763
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=3376155
|z Texto completo
|
| 938 |
|
|
|a Askews and Holts Library Services
|b ASKH
|n AH36567356
|
| 938 |
|
|
|a EBL - Ebook Library
|b EBLB
|n EBL3376155
|
| 994 |
|
|
|a 92
|b IZTAP
|
