Description |
1 online resource (viii, 73 pages) |
Contents |
""Expanding Access to Investigational Therapies for HIV Infection and AIDS""; ""Copyright""; ""PREFACE""; ""Contents""; ""EXPANDING ACCESS TO INVESTIGATIONAL THERAPIES FOR HIV INFECTION AND AIDS""; ""Expanding Access to Investigational Therapies March 12�13, 1990 Program""; ""1 HISTORICAL PERSPECTIVE""; ""EARLY DEVELOPMENT OF EXPANDED ACCESS""; ""Drug Amendments of 1962""; ""Access for Therapeutic Purposes""; ""Growing Confusion""; ""Modern Clinical Trials (Non-AIDS Drugs)""; ""THE ADVENT OF AIDS""; ""Broadening Participation""; ""Accelerating the Pace of Drug Development"" |
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Improving Response CapabilitiesExpedited Development -- Expanded Access -- Treatment Investigational New Drugs -- Parallel Track -- 2 RIGHTS AND RESPONSIBILITIES -- FREEDOM OF CHOICE -- INFORMED CONSENT -- Information Resources -- Access -- Primary Care -- Difficult Choices -- COMPETING RIGHTS -- INSTITUTIONAL REVIEW BOARDS -- NEW ATTITUDES -- 3 EVALUATION OF EXPANDED ACCESS PROGRAMS -- TREATMENT INVESTIGATIONAL NEW DRUGS -- POTENTIAL RISKS -- Examples from the Past -- The Target Population -- Safety Data |
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IMPACT ON CONVENTIONAL RANDOMIZED TRIALSTHE PARALLEL TRACK EXPERIMENT -- 4 CREATIVITY IN CLINICAL TRIALS -- THE CHANGING ENVIRONMENT -- CONVENTIONAL TRIALS -- PREFERENCE TRIALS -- LARGE, SIMPLE RANDOMIZED TRIALS -- Physician Participation -- Quality Control -- DATA FROM THE PARALLEL TRACK -- Efficacy Data -- Safety Data and Related Information -- Expectations -- 5 DRUG INNOVATION AND THE PHARMACEUTICAL INDUSTRY -- TIME TO COMMERCIALIZATION -- DIRECT COSTS OF EXPANDED ACCESS -- Manpower Needs -- Drug Costs -- The Small Manufacturer |
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PRODUCT LIABILITYConcerns Specific to the Parallel Track -- Potential Solutions -- 6 THIRD-PARTY PAYERS -- BLUE CROSS AND BLUE SHIELD -- HEALTH INSURANCE ASSOCIATION OF AMERICA -- HEALTH CARE FINANCING ADMINISTRATION -- Medicaid -- State Discretion -- Patient Care Costs -- Medicare -- RESOURCES FOR CLINICAL INVESTIGATION -- 7 IMPROVING ACCESS TO CARE -- PEOPLE OF COLOR -- Resource Considerations -- Suspicion -- Informed Consent -- WOMEN -- The Gender Perspective -- Risk Factors -- Protocol Development -- Women as Vectors -- A New Approach |
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THE PEDIATRIC POPULATIONScientific Issues -- Social Issues |
Analysis |
AIDS Chemotherapy Social United Congresses |
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HIV Chemotherapy Social United Congresses |
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Pharmacology, Social United Congresses |
Bibliography |
Includes bibliographical references |
Notes |
Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002. http://purl.oclc.org/DLF/benchrepro0212 MiAaHDL |
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English |
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Print version record |
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digitized 2010 HathiTrust Digital Library committed to preserve MiAaHDL pda |
Subject |
AIDS (Disease) -- Chemotherapy -- Social aspects -- United States -- Congresses
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Pharmacology, Experimental -- Social aspects -- United States -- Congresses
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HIV infections -- Chemotherapy -- Social aspects -- United States -- Congresses
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Institutional review boards (Medicine)
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Health services accessibility.
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Social control.
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AIDS (Disease)
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Children.
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Federal government.
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Human experimentation in medicine.
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Research.
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Risk.
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HIV infections.
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Risk assessment.
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Ethics committees.
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Liberty.
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Information services.
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Women.
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Medical care.
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Informed consent (Medical law)
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Minorities.
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Pharmaceutical industry.
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Methodology.
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Economics.
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Human rights.
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Sociology.
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Probabilities.
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Industries.
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Slow virus diseases.
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Non-governmental organizations.
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Science.
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National health services.
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Drugs.
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Health services administration.
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Communication.
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Immunological deficiency syndromes.
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Risk management.
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Lentivirus infections.
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Social sciences.
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Insurance.
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Therapeutics.
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Medical care -- Quality control.
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Statistics.
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Public health.
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Physical sciences.
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Humanities.
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Sexually transmitted diseases.
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Virus diseases.
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Misinformation.
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Ethics Committees, Research
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Government Regulation
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Health Services Accessibility
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Personal Autonomy
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Public Policy
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Random Allocation
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Research Design
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Social Control, Formal
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HIV Seropositivity
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Acquired Immunodeficiency Syndrome
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Child
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Federal Government
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Human Experimentation
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Information Dissemination
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Patient Selection
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Research
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Risk
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Socioeconomic Factors
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Government
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HIV Infections
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Insurance, Health
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Risk Assessment
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Ethics Committees
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Freedom
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Information Services
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Therapeutic Human Experimentation
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Women
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Clinical Trials as Topic
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Patient Care
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Vulnerable Populations
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Informed Consent
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Research Subjects
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Minority Groups
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Drugs, Investigational
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Drug Industry
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Financial Support
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Health Care Economics and Organizations
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Methods
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Economics
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Human Rights
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Sociology
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Probability
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Industry
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Principle-Based Ethics
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Slow Virus Diseases
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Ethics
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Epidemiologic Study Characteristics as Topic
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Professional Staff Committees
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Organizations
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Evaluation Studies as Topic
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Psychological Phenomena and Processes
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Jurisprudence
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Social Control Policies
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Delivery of Health Care
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Patient Rights
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Science
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Persons
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Health Services
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Epidemiologic Research Design
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Pharmaceutical Preparations
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Patient Care Management
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Population Characteristics
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Communication
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Age Groups
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Sexually Transmitted Diseases, Viral
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Immunologic Deficiency Syndromes
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Risk Management
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Epidemiologic Measurements
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Lentivirus Infections
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Social Sciences
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Information Science
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Biomedical Research
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Insurance
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Investigative Techniques
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Therapeutics
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Health Care Quality, Access, and Evaluation
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Quality Assurance, Health Care
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Technology, Industry, and Agriculture
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Statistics as Topic
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Professional Practice
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Public Health
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Natural Science Disciplines
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Health Care Evaluation Mechanisms
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Named Groups
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Financing, Organized
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Humanities
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Sexually Transmitted Diseases
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Chemicals and Drugs
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Epidemiologic Methods
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Virus Diseases
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Policy
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Psychiatry and Psychology
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children (people by age group)
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federal government.
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research (function)
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governments (administrative bodies)
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risk assessment.
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freedom.
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minorities.
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methodology.
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economics.
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sociology.
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probability.
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sciences (philosophy)
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risk management.
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social sciences.
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insurance.
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public health.
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physical sciences.
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humanities.
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women (female humans)
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science (modern discipline)
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treating (health care function)
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statistics.
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MEDICAL -- AIDS & HIV.
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HEALTH & FITNESS -- Diseases -- AIDS & HIV.
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Pharmacology, Experimental -- Social aspects
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Infections à VIH.
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Syndrome d'immunodéficience acquise.
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United States
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Genre/Form |
proceedings (reports)
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Conference papers and proceedings
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Conference papers and proceedings.
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Actes de congrès.
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Form |
Electronic book
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Author |
Roundtable for the Development of Drugs and Vaccines against AIDS (Institute of Medicine)
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ISBN |
058515547X |
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9780585155470 |