Running a tightrope: Regulatory challenges in the development of antiretrovirals

Antiviral Research

Volumn 85, Issue 1, 2010, Pages 232-240

  Naeger, Lisa K ^a   Struble, Kimberly A ^a   Murray, Jeffrey S ^a   Birnkrant, Debra B ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Accelerated approval; Clinical trial designs; Drug regulations; Expanded access; Fast track; HIV 1; PEPFAR; Resistance; Surrogate endpoint

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; AMPRENAVIR; ANTIRETROVIRUS AGENT; ATAZANAVIR; DARUNAVIR; DELAVIRDINE; DIDANOSINE; EFAVIRENZ; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; EMTRICITABINE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ENFUVIRTIDE; FORTAVASE; FOSAMPRENAVIR; INDINAVIR; LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR; MARAVIROC; NELFINAVIR; NEVIRAPINE; RITONAVIR; SAQUINAVIR; STAVUDINE; TENOFOVIR DISOPROXIL; TIPRANAVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; ZALCITABINE; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ANTIVIRAL RESISTANCE; CD4 LYMPHOCYTE COUNT; CHILD HEALTH CARE; CLINICAL RESEARCH; CLINICAL TRIAL; DRUG APPROVAL; DRUG CHOICE; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE ACCESS; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INFECTION PREVENTION; POSTMARKETING SURVEILLANCE; PREGNANT WOMAN; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REVIEW; UNITED STATES; VIRUS LOAD; VIRUS MUTATION;

ANTI-HIV AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG DISCOVERY; HIV INFECTIONS; HUMANS;

HUMAN IMMUNODEFICIENCY VIRUS 1;

EID: 73549117041     PISSN: 01663542     EISSN: 18729096     Source Type: Journal    
DOI: 10.1016/j.antiviral.2009.07.016     Document Type: Review

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