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J-GLOBAL ID:201002269295823714   Reference number:10A1008473

Process analytical technology (PAT) for biopharmaceutical products

バイオ医薬品のためのProcess Analytical Technology(PAT)
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Material:
Volume: 398  Issue:Page: 137-154  Publication year: Sep. 2010 
JST Material Number: E0425B  ISSN: 1618-2642  Document type: Article
Article type: 文献レビュー  Country of issue: Germany, Federal Republic of (DEU)  Language: ENGLISH (EN)
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All keywords is available on JDreamIII(charged).
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JST classification (2):
JST classification
Category name(code) classified by JST.
Production in general  ,  Process control 
Reference (156):
  • U.S. Department of Health and Human Services, Food and Drug Administration (2002) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836 Accessed 10 Feb 2010
  • U.S. Department of Health and Human Services, Food and Drug Administration (2001) A presentation at the Advisory Committee for Pharmaceutical Science by Dr. Ajaz S. Hussain http://www.fda.gov/ohrms/dockets/ac/cder01.htm#Pharmaceutical%20Science Accessed 10 Feb 2010
  • Hinz DC (2006) Anal Bioanal Chem 384:1036-1041
  • Miller RW (2002) Am Pharm Rev 5(2):25-29
  • Miller RW (2003) Am Pharm Rev 6(1):52-61
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