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Volumn 42, Issue , 2013, Pages 157-167

Design Spaces for analytical methods

Author keywords

Analytical method development; Design of Experiments; Design Space (DS); Desirability function; Mean response surface; Optimization; Probability map; Quality assurance; Quality by Design (QbD); Robustness

Indexed keywords

DESIGN OF EXPERIMENTS; OPTIMIZATION; QUALITY ASSURANCE; ROBUSTNESS (CONTROL SYSTEMS); SURFACE PROPERTIES;

EID: 84871522634     PISSN: 01659936     EISSN: 18793142     Source Type: Journal    
DOI: 10.1016/j.trac.2012.09.007     Document Type: Review
Times cited : (225)

References (78)
  • 1
    • 84871525970 scopus 로고    scopus 로고
    • US Food and Drug Administration (FDA), Department of Health and Human Services, Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report, May
    • US Food and Drug Administration (FDA), Department of Health and Human Services, Pharmaceutical Quality for the 21st Century A Risk-Based Approach Progress Report, May 2007. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm128080.html.
    • (2007)
  • 2
    • 84871503282 scopus 로고    scopus 로고
    • US Food and Drug Administration (FDA), Guidance for industry PAT-A framework for innovative pharmaceutical manufacturing and quality assurance, FDA, Washington, DC, USA
    • US Food and Drug Administration (FDA), Guidance for industry PAT-A framework for innovative pharmaceutical manufacturing and quality assurance, FDA, Washington, DC, USA, 2004.
    • (2004)
  • 3
    • 84871506270 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8 (R2): Pharmaceutical Development, ICH, Geneva, Switzerland
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q8 (R2): Pharmaceutical Development, ICH, Geneva, Switzerland, 2009.
    • (2009)
  • 4
    • 84871511590 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, ICH, Geneva, Switzerland
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q9: Quality Risk Management, ICH, Geneva, Switzerland, 2005.
    • (2005)
  • 5
    • 84871524985 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q10: Pharmaceutical Quality System, ICH, Geneva, Switzerland
    • International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Topic Q10: Pharmaceutical Quality System, ICH, Geneva, Switzerland, 2008.
    • (2008)
  • 25
    • 84871500366 scopus 로고
    • What is Total Quality Control? The Japanese Way, Prentice-Hall, Englewood Cliffs, NJ, USA
    • K. Ishikawa, What is Total Quality Control? The Japanese Way, Prentice-Hall, Englewood Cliffs, NJ, USA, 1985, pp. 63-64.
    • (1985) , pp. 63-64
    • Ishikawa, K.1
  • 28
    • 0003600750 scopus 로고    scopus 로고
    • Second Edition, ASQ Quality Press, Milwaukee, WI, USA, FMEA from Theory to Execution
    • Stamatis D. Failure Modes and Effects Analysis 2003, Second Edition, ASQ Quality Press, Milwaukee, WI, USA, FMEA from Theory to Execution.
    • (2003) Failure Modes and Effects Analysis
    • Stamatis, D.1
  • 33
    • 84871493367 scopus 로고    scopus 로고
    • International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland
    • International Conference on Harmonization (ICH) of Technical Requirements for registration of Pharmaceuticals for Human Use, Topic Q2 (R1): Validation of Analytical Procedures: Text and Methodology, ICH, Geneva, Switzerland, 2005.
    • (2005)
  • 50
  • 60
    • 84871500836 scopus 로고    scopus 로고
    • J.J. Peterson. http://www.pharmamanufacturing.com/articles/2010/097.html.
    • Peterson, J.J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.