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Volumn 5, Issue 10, 2010, Pages

Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: Lessons learned from a microbicide phase III clinical trial

Author keywords

[No Author keywords available]

Indexed keywords

CELLULOSE SULFATE; PLACEBO; TOPICAL ANTIINFECTIVE AGENT;

EID: 78149459926     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0013592     Document Type: Article
Times cited : (8)

References (10)
  • 1
    • 48249154985 scopus 로고    scopus 로고
    • Lack of effectiveness of cellulose sulfate gel for prevention of vaginal HIV transmission
    • Van Damme L, Govinden R, Mirembe FM, Guedou F, Solomon S, et al. (2008) Lack of effectiveness of cellulose sulfate gel for prevention of vaginal HIV transmission. N Engl J Med 359: 463-72.
    • (2008) N Engl J Med , vol.359 , pp. 463-472
    • van Damme, L.1    Govinden, R.2    Mirembe, F.M.3    Guedou, F.4    Solomon, S.5
  • 2
    • 33845465536 scopus 로고    scopus 로고
    • Vaginal microbicides can interfere with nucleic acid amplification tests used for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection
    • Crucitti T, Jespers V, Van Damme L, Van Dyck E, Buvé A (2007) Vaginal microbicides can interfere with nucleic acid amplification tests used for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection. Diagn Microbiol Infect Dis 57: 97-9.
    • (2007) Diagn Microbiol Infect Dis , vol.57 , pp. 97-99
    • Crucitti, T.1    Jespers, V.2    van Damme, L.3    van Dyck, E.4    Buvé, A.5
  • 5
    • 36749084524 scopus 로고    scopus 로고
    • Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories
    • Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, et al. (2008) Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories. J Pharm Biomed Anal 46: 18-29.
    • (2008) J Pharm Biomed Anal , vol.46 , pp. 18-29
    • Ezzelle, J.1    Rodriguez-Chavez, I.R.2    Darden, J.M.3    Stirewalt, M.4    Kunwar, N.5
  • 6
    • 66349102222 scopus 로고    scopus 로고
    • Evaluation and recommendation on Good Clinical Laboratory Practice guideline for phase I-III clinical trials
    • doi:10.1371/journal. pmed.1000067
    • Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, et al. (2009) Evaluation and recommendation on Good Clinical Laboratory Practice guideline for phase I-III clinical trials. Plos Med 6(5): e1000067. doi:10.1371/journal. pmed.1000067.
    • (2009) Plos Med , vol.6 , Issue.5
    • Sarzotti-Kelsoe, M.1    Cox, J.2    Cleland, N.3    Denny, T.4    Hural, J.5
  • 7
    • 77951733997 scopus 로고    scopus 로고
    • Laboratory capacity building in Asia for infectious disease research: Experiences from the South East Asia Infectious Disease Clinical Research Network (SEAICRN)
    • doi: 10.1371/journal. pmed.1000231
    • Wertheim HF, Puthavathana P, Nghiem NM, van Doorn RH, Nguyen TV, et al. (2010) Laboratory capacity building in Asia for infectious disease research: experiences from the South East Asia Infectious Disease Clinical Research Network (SEAICRN). PLoS Med 7(4): e1000231. doi: 10.1371/journal. pmed.1000231.
    • (2010) PLoS Med , vol.7 , Issue.4
    • Wertheim, H.F.1    Puthavathana, P.2    Nghiem, N.M.3    van Doorn, R.H.4    Nguyen, T.V.5
  • 8
    • 50649115147 scopus 로고    scopus 로고
    • Good Clinical Practice in developing countries: Applying recommendations
    • o1, Giens XXIII
    • Bompart F, Hirsch F, Betroye P-H, Vray M, and The participants in Round Table No1, Giens XXIII (2008) Good Clinical Practice in developing countries: applying recommendations. Thérapie 63: 83-88.
    • (2008) Thérapie , vol.63 , pp. 83-88
    • Bompart, F.1    Hirsch, F.2    Betroye, P.-H.3    Vray, M.4
  • 9
    • 1542600254 scopus 로고    scopus 로고
    • Good Clinical Laboratory Practice (GCLP): The need for a hybrid of good laboratory practice and good clinical practice guidelines/ standards for medical testing laboratories conducting clinical trials in developing countries
    • Stevens W (2003) Good Clinical Laboratory Practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/ standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur 10: 83-89.
    • (2003) Qual Assur , vol.10 , pp. 83-89
    • Stevens, W.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.