메뉴 건너뛰기




Volumn 28, Issue 5, 2004, Pages 727-735

A decisional-support tool to model the impact of regulatory compliance activities in the biomanufacturing industry

Author keywords

Biotechnology; Modelling; Process development; QC QA; Simulation

Indexed keywords

BATCH DATA PROCESSING; COST BENEFIT ANALYSIS; DECISION SUPPORT SYSTEMS; QUALITY ASSURANCE; QUALITY CONTROL; REGULATORY COMPLIANCE; RESOURCE ALLOCATION; SOFTWARE PROTOTYPING; STRATEGIC PLANNING;

EID: 1842850971     PISSN: 00981354     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.compchemeng.2004.02.013     Document Type: Conference Paper
Times cited : (24)

References (17)
  • 1
    • 0034102259 scopus 로고    scopus 로고
    • Role and timing of process development for biopharmaceutical manufacture
    • Byrom D. Role and timing of process development for biopharmaceutical manufacture. Pharmaceutical Technology Europe. 12:2000;52-56.
    • (2000) Pharmaceutical Technology Europe , vol.12 , pp. 52-56
    • Byrom, D.1
  • 2
    • 0032802777 scopus 로고    scopus 로고
    • New and integrated approaches to successful accelerated drug development
    • Clemento A. New and integrated approaches to successful accelerated drug development. Drug Information Journal. 33:1999;669-710.
    • (1999) Drug Information Journal , vol.33 , pp. 669-710
    • Clemento, A.1
  • 3
    • 0033168756 scopus 로고    scopus 로고
    • Quality control and assurance from the development to the production of biopharmaceuticals
    • Doblhoff-Dier, O., & Bliem, R. (1999). Quality control and assurance from the development to the production of biopharmaceuticals. TIBTECH, 17, 266-270.
    • (1999) TIBTECH , vol.17 , pp. 266-270
    • Doblhoff-Dier, O.1    Bliem, R.2
  • 7
    • 0030052295 scopus 로고    scopus 로고
    • Regulatory reflections concerning the state of biotechnology progress
    • Fisher M.P., Pascucci V.L. Regulatory reflections concerning the state of biotechnology progress. Drug Information Journal. 30:1996;41-46.
    • (1996) Drug Information Journal , vol.30 , pp. 41-46
    • Fisher, M.P.1    Pascucci, V.L.2
  • 8
    • 0031039072 scopus 로고    scopus 로고
    • The challenge of managing quality control/quality assurance for loosely structured and virtual biopharmaceutical companies
    • Geigert J. The challenge of managing quality control/quality assurance for loosely structured and virtual biopharmaceutical companies. Drug Information Journal. 31:1997;97-100.
    • (1997) Drug Information Journal , vol.31 , pp. 97-100
    • Geigert, J.1
  • 10
    • 0035703447 scopus 로고    scopus 로고
    • Seamless process development: Enhancing speed to market and reducing costs
    • Norris, P. (2001). Seamless process development: Enhancing speed to market and reducing costs, PharmaceuticalVisions, 36-39.
    • (2001) PharmaceuticalVisions , pp. 36-39
    • Norris, P.1
  • 11
    • 0028320729 scopus 로고
    • BioPro designer: An advanced computing environment for modelling and design of integrated biochemical processes
    • Petrides D.P. BioPro designer: An advanced computing environment for modelling and design of integrated biochemical processes. Computers and Chemical Engineering. 18(Suppl.):1994;S621-S625.
    • (1994) Computers and Chemical Engineering , vol.18 , Issue.SUPPL. , pp. 621-S625
    • Petrides, D.P.1
  • 16
    • 0034241572 scopus 로고    scopus 로고
    • Biopharmaceutical benchmarks
    • Walsh G. Biopharmaceutical benchmarks. Nature Biotechnology. 18:2000;831-833.
    • (2000) Nature Biotechnology , vol.18 , pp. 831-833
    • Walsh, G.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.