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Volumn 36, Issue 5, 2012, Pages 73-80

Scientific considerations of forced degradation studies in anda submissions

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG DEGRADATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG POTENCY; DRUG PURITY; DRUG QUALITY; DRUG STABILITY; OXIDATION; PHOTOLYSIS; TEMPERATURE STRESS; THERMOSTABILITY;

EID: 84870028637     PISSN: 15432521     EISSN: 21507376     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (30)

References (18)
  • 7
    • 13444273611 scopus 로고    scopus 로고
    • S. Klick, et al., Pharm.Technol. 29 (2) 48-66 (2005).
    • (2005) Pharm.Technol , vol.29 , Issue.2 , pp. 48-66
    • Klick, S.1
  • 11
    • 84870020043 scopus 로고    scopus 로고
    • FDA, Guidance for Industry on Analytical Procedures and methods Validation Chemistry, Rockville, MD, Aug
    • FDA, Guidance for Industry on Analytical Procedures and methods Validation Chemistry, Manufacturing, and Controls Documentation (draft) (Rockville, MD, Aug. 2000).
    • (2000) Manufacturing, and Controls Documentation (draft)
  • 17
    • 55849151593 scopus 로고    scopus 로고
    • EMA, Committee for Medical Products for Human Use (CHMP) (Doc. Ref EMA/ CHMP/QWP/251344/2006) (Jan. 1
    • EMA, Guideline on the Limits of Genotoxic Impurities, Committee for Medical Products for Human Use (CHMP) (Doc. Ref EMA/ CHMP/QWP/251344/2006) (Jan. 1, 2007).
    • (2007) Guideline On the Limits of Genotoxic Impurities


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.