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Volumn 34, Issue 8, 2010, Pages 45-51

Common deficiences in abbreviated new durg application Part 2: Description, composition, and excipients

Author keywords

[No Author keywords available]

Indexed keywords

ARACHIS OIL; ASPARTAME; BENZYL ALCOHOL; CASTOR OIL; COLORING AGENT; CROSPOVIDONE; IRON OXIDE; MACROGOL; METHACRYLIC ACID; POVIDONE;

EID: 78651274873     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (10)

References (17)
  • 6
    • 78651308868 scopus 로고    scopus 로고
    • FDA, Dosage Form, CDER Data Element Number, C DRG 00201 (Dec. 15)
    • FDA, Data Standards Manual (monographs), Dosage Form, CDER Data Element Number, C DRG 00201 (Dec. 15, 2006)
    • (2006) Data Standards Manual (Monographs)
  • 13
    • 78651336660 scopus 로고    scopus 로고
    • USP 32 NF 27 (USP, Rockville, MD, 2010)
    • USP 32 NF 27 (USP, Rockville, MD, 2010).
  • 15
    • 78651316110 scopus 로고    scopus 로고
    • Food and Chemicals Codex 6 (USP, Rockville, MD, 2010)
    • Food and Chemicals Codex 6 (USP, Rockville, MD, 2010).
  • 16
    • 78651333916 scopus 로고    scopus 로고
    • IPEC Americas, Arlington, VA
    • IPEC Americas, Excipient Master File Guide (Arlington, VA, 2004).
    • (2004) Excipient Master File Guide
  • 17
    • 6144274723 scopus 로고    scopus 로고
    • FDA, [Testing and Approval or Rejection of Components, Drug Product Containers, and Closures, Sec. 211.84 (d) (2)]
    • FDA, "21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceutical," [Testing and Approval or Rejection of Components, Drug Product Containers, and Closures, Sec. 211.84 (d) (2)].
    • 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceutical


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.