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Volumn 5, Issue 4, 2010, Pages 193-203

An example of utilizing mechanistic and empirical modeling in quality by design

Author keywords

Design space; Empirical modeling; Mechanistic modeling; Quality by design; Verification

Indexed keywords

ARTICLE; CASE REPORT; CHEMICAL REACTION; DRUG IMPURITY; ETHANOLYSIS; HUMAN; LACTAMIZATION; MECHANICS; MODEL; PHARMACEUTICAL CARE; PHARMACEUTICAL ENGINEERING; PRIORITY JOURNAL; PROCESS DESIGN; QUALITY BY DESIGN; QUALITY CONTROL;

EID: 79952705765     PISSN: 18725120     EISSN: None     Source Type: Journal    
DOI: 10.1007/s12247-010-9094-y     Document Type: Article
Times cited : (34)

References (8)
  • 1
    • 38349053344 scopus 로고    scopus 로고
    • JPI interviews Moheb Nasr, Ph.D.: Director, Office of New Drug Quality Assesment (ONDQA), CDER, US FDA
    • JPI interviews Moheb Nasr, Ph.D.: Director, Office of New Drug Quality Assesment (ONDQA), CDER, US FDA. Journal of Pharmaceutical Innovation. 2007;2:67-70
    • (2007) Journal of Pharmaceutical Innovation , vol.2 , pp. 67-70
  • 2
    • 38349060175 scopus 로고    scopus 로고
    • Development knowledge can increase manufacturing capability and facilitate quality by design
    • Somma R. Development knowledge can increase manufacturing capability and facilitate quality by design. Journal of Pharmaceutical Innovation. 2007;2:87-92.
    • (2007) Journal of Pharmaceutical Innovation , vol.2 , pp. 87-92
    • Somma, R.1
  • 6
    • 70350208809 scopus 로고    scopus 로고
    • Quality by design case study: An integrated multivariate approach to drug product and process development
    • Huang J, Kaul G, Cai C, Chatlapalli R, Hernandez-Abad P, Ghosh K, et al. Quality by design case study: an integrated multivariate approach to drug product and process development. Int J Pharm. 2009;382:23-32.
    • (2009) Int J Pharm , vol.382 , pp. 23-32
    • Huang, J.1    Kaul, G.2    Cai, C.3    Chatlapalli, R.4    Hernandez-Abad, P.5    Ghosh, K.6
  • 8
    • 0015991398 scopus 로고
    • Molecular thermodynamics for chemical reaction design
    • Eckert CA, Hsieh CK, McCabe JR. Molecular thermodynamics for chemical reaction design. AlChE J. 1974;20:20-36.
    • (1974) AlChE J , vol.20 , pp. 20-36
    • Eckert, C.A.1    Hsieh, C.K.2    McCabe, J.R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.