Testing strategies in multi-dose experiments including active control

被引:0
|
作者
Bauer, P
Rohmel, J
Maurer, W
Hothorn, L
机构
[1] Univ Vienna, Inst Med Stat, A-1090 Vienna, Austria
[2] Bundesinst Arzneimittel & Med Prod, D-13353 Berlin, Germany
[3] Novartis Pharma AG, MIPS Biostat, CH-4002 Basel, Switzerland
[4] Univ Hannover, FB Gartenbau, LG Bioinformat, D-30419 Hannover, Germany
关键词
D O I
10.1002/(SICI)1097-0258(19980930)17:18<2133::AID-SIM901>3.0.CO;2-2
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
Inferential test strategies for multi-arm trials are adapted or proposed for the special situation when more than one dose of a test treatment, placebo and active control(s) are compared. This includes between doses, dose-placebo and dose-active-control comparisons. The procedures refer to situations when detailed comparisons make sense only if the sensitivity of the trial has been shown, for example, if a dose-response relationship or a difference between active control and placebo has been established. Split strategies, hierarchical (assuming an order restriction among doses) or linked procedures are introduced. In linked procedures, equivalence to the active control will be established only if the dose is also shown to be effective as compared to placebo. All the inferential procedures control the experimentwise error rate in the strong sense for the respective sets of null hypotheses considered. (C) 1998 John Wiley & Sons, Ltd.
引用
收藏
页码:2133 / 2146
页数:14
相关论文
共 50 条
  • [41] Delivery of salbutamol and of budesonide from a novel multi-dose inhaler Airmax™
    Zeng, XM
    O'Leary, D
    Phelan, M
    Jones, S
    Colledge, J
    RESPIRATORY MEDICINE, 2002, 96 (06) : 404 - 411
  • [42] MULTI-DOSE COMPARATIVE-STUDY OF MICROCRYSTALLINE THEOPHYLLINE AND CHOLINE THEOPHYLLINATE
    BERG, WC
    JONKMAN, JHG
    DEVRIES, K
    ORIE, NGM
    CURRENT MEDICAL RESEARCH AND OPINION, 1979, 6 : 64 - 70
  • [43] A PILOT EXPERIMENT FOR THE MICRONUCLEUS TEST - THE MULTI-SAMPLING AT MULTI-DOSE LEVELS METHOD
    HAYASHI, M
    SOFUNI, T
    ISHIDATE, M
    MUTATION RESEARCH, 1984, 141 (3-4): : 165 - 169
  • [44] Vizilatan® Preservative-free eye drops in multi-dose vials
    不详
    ACTUALITES PHARMACEUTIQUES, 2020, 59 (592): : 11 - 11
  • [45] Disposition of cyclosporine after intravenous and multi-dose oral administration in cats
    Mehl, ML
    Kyles, AE
    Craigmill, AL
    Epstein, S
    Gregory, CR
    JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS, 2003, 26 (05) : 349 - 354
  • [46] Time Scale Calculus: a new approach to multi-dose pharmacokinetic modeling
    Arteaga-Bejarano, Jose Ricardo
    Torres, Santiago
    JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS, 2024, 51 (06) : 825 - 839
  • [47] Pharmacokinetics of paracetamol in the Thoroughbred horse following an oral multi-dose administration
    Pesko, Bogumila
    Habershon-Butcher, Jocelyn
    Muir, Tessa
    Gray, Bob
    Taylor, Polly
    Fenwick, Susanna
    Hincks, Pamela
    Scarth, James
    Paine, Stuart
    JOURNAL OF VETERINARY PHARMACOLOGY AND THERAPEUTICS, 2022, 45 (01) : 54 - 62
  • [48] Preservative of choice for Prev(e)nar 13™ in a multi-dose formulation
    Khandke, Lakshmi
    Yang, Cindy
    Krylova, Ksenia
    Jansen, Kathrin U.
    Rashidbaigi, Abbas
    VACCINE, 2011, 29 (41) : 7144 - 7153
  • [49] Association between multi-dose drug dispensing and drug treatment changes
    Christina Sjöberg
    Henrik Ohlsson
    Susanna M Wallerstedt
    European Journal of Clinical Pharmacology, 2012, 68 : 1095 - 1101
  • [50] Effects of intrathecal nicardipine on cerebral microvascular perfusion: A multi-dose study
    Samuels, Owen
    JOURNAL OF THE NEUROLOGICAL SCIENCES, 2023, 455