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Volumn 91, Issue , 1997, Pages 3-13
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FDA perspective on specifications for biotechnology products--from IND to PLA.
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Author keywords
[No Author keywords available]
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Indexed keywords
DRUG;
MONOCLONAL ANTIBODY;
RECOMBINANT PROTEIN;
BIOTECHNOLOGY;
DRUG APPROVAL;
DRUG CONTAMINATION;
DRUG DESIGN;
DRUG INDUSTRY;
DRUG SCREENING;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
ISOLATION AND PURIFICATION;
METHODOLOGY;
PHARMACEUTICS;
PHASE 1 CLINICAL TRIAL;
PHASE 4 CLINICAL TRIAL;
QUALITY CONTROL;
REVIEW;
STANDARD;
UNITED STATES;
ANTIBODIES, MONOCLONAL;
BIOPHARMACEUTICS;
BIOTECHNOLOGY;
CLINICAL TRIALS, PHASE I;
CLINICAL TRIALS, PHASE IV;
DRUG APPROVAL;
DRUG CONTAMINATION;
DRUG DESIGN;
DRUG EVALUATION;
DRUG INDUSTRY;
HUMANS;
PHARMACEUTICAL PREPARATIONS;
QUALITY CONTROL;
RECOMBINANT PROTEINS;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 0031308296
PISSN: 03015149
EISSN: None
Source Type: Journal
DOI: None Document Type: Review |
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Times cited : (23)
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References (0)
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