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Volumn 60, Issue 2, 2005, Pages
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Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and monoclonal antibodies
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NONE
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Author keywords
[No Author keywords available]
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Indexed keywords
ADALIMUMAB;
AMLODIPINE BESYLATE;
ANTIHYPERTENSIVE AGENT;
BETA ADRENERGIC RECEPTOR BLOCKING AGENT;
BETA1A INTERFERON;
CALCIUM CHANNEL BLOCKING AGENT;
DROTRECOGIN;
ETANERCEPT;
GENERIC DRUG;
HUMAN GROWTH HORMONE;
HUMAN MENOPAUSAL GONADOTROPIN;
INFLIXIMAB;
INTERFERON BETA SERINE;
METOPROLOL SUCCINATE;
MONOCLONAL ANTIBODY;
NEW DRUG;
OKT 3;
OMNITROP;
ORPHAN DRUG;
PEGINTERFERON ALPHA2A;
PEGINTERFERON ALPHA2B;
PEGVISOMANT;
RECOMBINANT ALPHA2A INTERFERON;
RECOMBINANT ALPHA2B INTERFERON;
RECOMBINANT ERYTHROPOIETIN;
RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;
RECOMBINANT VACCINE;
RITUXIMAB;
SMALLPOX VACCINE;
SOMATREM;
UNCLASSIFIED DRUG;
UNINDEXED DRUG;
AMINO ACID SEQUENCE;
AREA UNDER THE CURVE;
BIOTECHNOLOGY;
BLOOD COMPONENT THERAPY;
DRUG APPROVAL;
DRUG BIOAVAILABILITY;
DRUG DESIGN;
DRUG HALF LIFE;
DRUG INDICATION;
DRUG INDUSTRY;
DRUG RESEARCH;
FOOD AND DRUG ADMINISTRATION;
GLYCOSYLATION;
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;
HISTORY OF MEDICINE;
HUMAN;
LAW SUIT;
MEDICOLEGAL ASPECT;
MULTIPLE SCLEROSIS;
NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY;
POLYACRYLAMIDE GEL ELECTROPHORESIS;
PROTEIN SYNTHESIS;
RECOMBINANT DNA TECHNOLOGY;
REVIEW;
RHEUMATOID ARTHRITIS;
SCIENCE;
SEPSIS;
ANTIBODIES, MONOCLONAL;
BIOLOGICAL PRODUCTS;
BIOTECHNOLOGY;
BLOOD;
CONSUMER PRODUCT SAFETY;
DRUG APPROVAL;
DRUGS, GENERIC;
HISTORY, 19TH CENTURY;
HISTORY, 20TH CENTURY;
HISTORY, 21ST CENTURY;
HUMANS;
LEGISLATION, DRUG;
RECOMBINANT PROTEINS;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 23444450198
PISSN: 1064590X
EISSN: None
Source Type: Journal
DOI: None Document Type: Review |
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Times cited : (28)
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References (0)
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