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Volumn 20, Issue 9-10, 2002, Pages 1261-1280
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The HIV/AIDS vaccine researchers' orientation to the process of preparing a US FDA application for an investigational new drug (IND): What it is all about and how you start by preparing for your pre-IND meeting
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Author keywords
[No Author keywords available]
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Indexed keywords
DNA VACCINE;
HUMAN IMMUNODEFICIENCY VIRUS VACCINE;
INACTIVATED VIRUS VACCINE;
VIRUS VACCINE;
VIRUS VECTOR;
ACQUIRED IMMUNE DEFICIENCY SYNDROME;
BIOCHEMISTRY;
CELL;
CLINICAL PROTOCOL;
CLINICAL STUDY;
CLINICAL TRIAL;
DRUG ACTIVITY;
DRUG APPROVAL;
DRUG FORMULATION;
DRUG INFORMATION;
DRUG MANUFACTURE;
DRUG POTENCY;
DRUG RESEARCH;
DRUG SAFETY;
DRUG SCREENING;
EXPERIMENTAL DESIGN;
FOOD AND DRUG ADMINISTRATION;
GOOD LABORATORY PRACTICE;
GOOD MANUFACTURING PRACTICE;
HUMAN;
HUMAN IMMUNODEFICIENCY VIRUS INFECTION;
PHASE 1 CLINICAL TRIAL;
PRIORITY JOURNAL;
PROCESS CONTROL;
QUALITY CONTROL;
RISK BENEFIT ANALYSIS;
SHORT SURVEY;
TOXICITY TESTING;
VALIDATION PROCESS;
AIDS VACCINES;
ANIMALS;
CLINICAL TRIALS;
HUMANS;
INVESTIGATIONAL NEW DRUG APPLICATION;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 0037203798
PISSN: 0264410X
EISSN: None
Source Type: Journal
DOI: 10.1016/S0264-410X(01)00453-4 Document Type: Short Survey |
Times cited : (12)
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References (10)
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