Development of specifications for biotechnology products--perspective from Europe.
Trouvin
J H
JH
Agence du Médicament, Unité Biologie, Saint-Denis, France.
D001702:Biopharmaceutics / Q000592:standards*; D001709:Biotechnology / Q000592:standards*; D017277:Drug Approval; D004340:Drug Contamination; D004341:Drug Evaluation / Q000592:standards; D004345:Drug Industry / Q000379:methods / Q000592:standards*; D005060:Europe; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D011786:Quality Control; D011994:Recombinant Proteins / Q000592:standards; D012449:Safety
D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins