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Volumn 44, Issue 5, 2010, Pages 581-588

Statistical considerations for the efficacy assessment of clinical studies of vulvar and vaginal atrophy

Author keywords

Atrophic vaginitis; Coprimary endpoints; Efficacy assessment; Menopause; Vulvar and vaginal atrophy indication

Indexed keywords

GESTAGEN; PLACEBO;

EID: 78650182297     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151004400505     Document Type: Review
Times cited : (10)

References (9)
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  • 3
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    • Multiple co-primary endpoints: Medical and statistical solutions - A report from the multiple endpoints expert team of the Pharmaceutical Research and Manufacturers of America
    • Offen W, Chuang-Stein C, Dmitrienko A, et al. Multiple co-primary endpoints: medical and statistical solutions - a report from the multiple endpoints expert team of the Pharmaceutical Research and Manufacturers of America. Drug Inf J. 2007;41(1):31-46.
    • (2007) Drug Inf J. , vol.41 , Issue.1 , pp. 31-46
    • Offen, W.1    Chuang-Stein, C.2    Dmitrienko, A.3
  • 4
    • 78650223645 scopus 로고    scopus 로고
    • Type I error rate and sample size issues for confirmatory trials with co-primary endpoints
    • Paper presented at the
    • Huque MF, Chen L, Sobhan M. Type I error rate and sample size issues for confirmatory trials with co-primary endpoints. Paper presented at the 2nd FDA/DIA Statistics Forum, Washington, DC, 2008.
    • 2nd FDA/DIA Statistics Forum, Washington, DC, 2008
    • Huque, M.F.1    Chen, L.2    Sobhan, M.3
  • 6
    • 78650196233 scopus 로고    scopus 로고
    • Statistical issues with multiple co-primary endpoints in vulvar and vaginal atrophy clinical studies
    • Paper presented at
    • Chen L. Statistical issues with multiple co-primary endpoints in vulvar and vaginal atrophy clinical studies. Paper presented at 2008 ICSA Applied Statistics Symposium, Piscataway, New Jersey.
    • 2008 ICSA Applied Statistics Symposium, Piscataway, New Jersey
    • Chen, L.1
  • 7
    • 78650200543 scopus 로고    scopus 로고
    • Statistical testing for multiple co-primary endpoints in clinical trials: Type I error rate concepts and sample size issues
    • Paper presented at
    • Huque MF. Statistical testing for multiple co-primary endpoints in clinical trials: type I error rate concepts and sample size issues. Paper presented at 2008 ICSA Applied Statistics Symposium, Piscataway, New Jersey.
    • 2008 ICSA Applied Statistics Symposium, Piscataway, New Jersey
    • Huque, M.F.1
  • 8
    • 0034530370 scopus 로고    scopus 로고
    • Practical guidelines for multiplicity adjustment in clinical trials
    • Proschan MA, Waclawiw MA. Practical guidelines for multiplicity adjustment in clinical trials. Control Clin Trials. 2000;21:527-539.
    • (2000) Control Clin Trials , vol.21 , pp. 527-539
    • Proschan, M.A.1    Waclawiw, M.A.2
  • 9
    • 27744570591 scopus 로고    scopus 로고
    • Management of post-menopausal vaginal atrophy and atrophic vaginitis
    • Castelo-Branco C, Cancelo M, Villero J, Nohales F. Management of post-menopausal vaginal atrophy and atrophic vaginitis. Maturitas. 2005;52:46-52.
    • (2005) Maturitas , vol.52 , pp. 46-52
    • Castelo-Branco, C.1    Cancelo, M.2    Villero, J.3    Nohales, F.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.