Regulatory challenges in microbicide development

Science

Volumn 304, Issue 5679, 2004, Pages 1911-1912

  Coplan, Paul M ^a   Mitchnick, Mark ^a   Rosenberg, Zeda F ^a  

^a INTERNATIONAL PARTNERSHIP FOR MICROBICIDES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; ANTIRETROVIRUS AGENT; LAMIVUDINE PLUS ZIDOVUDINE; ZIDOVUDINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; PLACEBO;

PESTICIDE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CLINICAL TRIAL; CONDOM; DECISION MAKING; DEVELOPING COUNTRY; DRUG EFFICACY; DRUG LEGISLATION; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GEL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LICENSING; PRIORITY JOURNAL; REVIEW; RISK BENEFIT ANALYSIS; SEXUAL BEHAVIOR; SEXUAL TRANSMISSION; WORLD HEALTH ORGANIZATION; ADVISORY COMMITTEE; ANIMAL; ARTICLE; CONTROLLED CLINICAL TRIAL; DISEASE TRANSMISSION; DRUG APPROVAL; DRUG COMBINATION; DRUG EFFECT; DRUG SCREENING; FEMALE; FINANCIAL MANAGEMENT; GOVERNMENT REGULATION; HUMAN IMMUNODEFICIENCY VIRUS; INTRAVAGINAL DRUG ADMINISTRATION; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RECTAL DRUG ADMINISTRATION;

HUMAN IMMUNODEFICIENCY VIRUS;

ADMINISTRATION, INTRAVAGINAL; ADMINISTRATION, RECTAL; ADVISORY COMMITTEES; ANIMALS; ANTI-HIV AGENTS; CLINICAL TRIALS, PHASE III; CONDOMS; DRUG APPROVAL; DRUG EVALUATION, PRECLINICAL; DRUG THERAPY, COMBINATION; FEMALE; FINANCIAL SUPPORT; GOVERNMENT REGULATION; HIV; HIV INFECTIONS; HUMANS; PATIENT SELECTION; PLACEBOS; RANDOMIZED CONTROLLED TRIALS;

EID: 3042674950     PISSN: 00368075     EISSN: None     Source Type: Journal    
DOI: 10.1126/science.1100441     Document Type: Review

References (20)

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20. We thank P. Kahn and M. Gross for valuable input on the manuscript and J. Mitstein, P. Harrison, T. Farley, L. Heise, H. Rees, G. Ramjee, and the Intemational Working Group on Microbicides for productive discussions.