A Meta-analysis to Assess the FDA DAVP’s TLOVR Algorithm in HIV Submissions

Author:

Smith Fraser,Hammerstrom Thomas,Soon Greg,Zhou Susan,Chen Baibai,Mai Yabing,Struble Kimberly,Huque Mohammad

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)

Reference9 articles.

1. Chuang-Stcin C. DeMasi R. Surrogate endpoints in AIDS drug development: current status. Drug Inf J. 1998;32:439–448.

2. Marschner IC, Collier AC, Coombs RW, et al. Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess the clinical benefit of antiretroviral therapy. J Infect Dis. 1998; 177:40–47.

3. Hill AM, DeMasi R. Dawson D. Meta-analysis of antiretroviral effects on HIV-1 RNA. CD4 cell count and progression to AIDS or death. Antiviral Ther. 1998;3:139–145.

4. Division of Antiviral Drug Products. Office of Drug Evaluation IV. Center for Drug Evaluation and Research. Food and Drug Administration. Guidance for industry. Antiretroviral drugs using plasma HIV RNA measurements—clinical considerations for accelerated and traditional approval. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRcgulatoryInformation/Guidances/ucm070968.pdf.

5. Murray JS. Elashoff MR. lacono-Connors LC, et al. The use of plasma HIV RNA as a study end-point in efficacy trials of antiretroviral drugs. AIDS. 1999;13:797–804.

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