How do we assure the quality of biological medicines?

Drug Discovery Today

Volumn 14, Issue 1-2, 2009, Pages 50-55

  Longstaff, Colin ^a   Whitton, Colin M ^a   Stebbings, Richard ^a   Gray, Elaine ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL FACTOR; BIOSIMILAR; CHONDROITIN SULFATE; DERMATAN SULFATE; GENERIC DRUG; HEPARIN; PLACEBO; STREPTOKINASE; TGN 1412; UNCLASSIFIED DRUG;

ALLERGIC REACTION; CARDIOGENIC SHOCK; CHRONIC LYMPHATIC LEUKEMIA; DEATH; DEVELOPING COUNTRY; DISSEMINATED INTRAVASCULAR CLOTTING; DRUG CONTAMINATION; DRUG INDICATION; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG SAFETY; EUROPE; FEVER; FIBRINOLYTIC THERAPY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HEART INFARCTION; HEMOLYTIC STREPTOCOCCUS; HEPARIN INDUCED THROMBOCYTOPENIA; HISTORY; HUMAN; HYPOTENSION; LAW; LICENSING; MACACA; MULTIPLE ORGAN FAILURE; NONHUMAN; PAIN; QUALITY CONTROL; RESPIRATORY DISTRESS; REVIEW; RHEUMATOID ARTHRITIS; SIDE EFFECT; STANDARDIZATION; VOLUNTEER; WORLD HEALTH ORGANIZATION;

ANTIBODIES, MONOCLONAL; BIOLOGICAL PRODUCTS; DRUG INDUSTRY; HEPARIN; HUMANS; LEGISLATION, DRUG; QUALITY CONTROL; STREPTOKINASE;

EID: 58149114713     PISSN: 13596446     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.drudis.2008.09.010     Document Type: Review

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