Application of quality by design principles to legacy drug products

Journal of Pharmaceutical Innovation

Volumn 6, Issue 2, 2011, Pages 61-68

  Yacoub, Francois ^a   Lautens, Julie ^a   Lucisano, Leo ^a   Banh, Wendy ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Control strategy; Design space; Feedback control; Multivariate statistical modeling; Optimization; Partial least squares; Quality by design

Indexed keywords

CONTROL STRATEGY; DATA BASE; DRUG DESIGN; DRUG MANUFACTURE; DRUG QUALITY; EXPERIMENTAL DESIGN; FEEDBACK SYSTEM; PHARMACEUTICAL ENGINEERING; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUALITY CONTROL; REVIEW;

EID: 79960466177     PISSN: 18725120     EISSN: 19398042     Source Type: Journal    
DOI: 10.1007/s12247-011-9101-y     Document Type: Review

References (16)

1. ICH Harmonized Tripartite Document, Pharmaceutical Development, Q8. Nov 2005.
2. GEP Box 1953 Non-normality and tests on variances Biometrika 40 318 35
3. GEP Box SL Andersen 1955 Permutation theory in the derivation of robust criteria and the study of departures from assumption J R Stat Soc B 17 1 34
4. Taguchi G. Introduction to quality engineering-designing quality into products and processes. Tokyo: Asian Productivity Organization; 1986. p. 122.
5. VN Nair 1992 Taguchi's parameter design: a panel discussion Technometrics 34 127 61 10.2307/1269231
6. RV Leon AC Shoemaker RN Kackar 1987 Performance measure independent of adjustment: an explanation and extension of Taguchi's signal to noise ratio Technometrics 29 253 85 10.2307/1269331
7. Ross P. Taguchi techniques for quality engineering. London: McGraw-Hill; 1996.
8. C Potter Industry Working Group 2009 PQLI of application science- and risk-based approaches (ICH Q8, Q9, and Q10) to existing products J Pharma Innov 4 4 23 10.1007/s12247-009-9051-9
9. AJ Westerhuis T Kourti JF MacGregor 1998 Analysis of multiblock and hierarchical PCA and PLS models J Chemometr 12 301 321 10.1002/(SICI)1099- 128X(199809/10)12:5<301::AID-CEM515>3.0.CO;2-S 1:CAS:528: DyaK1cXntFCqsrs%3D (Pubitemid 128480027)
10. JF MacGregor C Jaeckle C Kiparissides M Koutodi 1994 Process monitoring and diagnosis by multiblock PLS methods AIChE J 40 826 8 10.1002/aic.690400509 1:CAS:528:DyaK2cXjt1Kktr4%3D
11. JF MacGregor M-J Bruwer 2008 A framework for the development of design and control spaces J Pharm Innov 3 15 22 10.1007/s12247-008-9023-5
12. Box GEP, Hunter WG, Hunter JS. Statistics for experimenters: an introduction to design, data analysis, and model building. New York: Wiley; 1978.
13. WJ Hill WG Hunter 1966 A review of response surface methodology: a literature survey Technometrics 8 4 571 90 10.2307/1266632
14. F Yacoub JF MacGregor 2004 Product optimization and control in the latent variable space of nonlinear PLS models Chemom Intell Lab Syst 70 63 74 10.1016/j.chemolab.2003.10.004 1:CAS:528:DC%2BD2cXksFSktA%3D%3D (Pubitemid 38102219)
15. F Yacoub JF MacGregor 2010 Robust processes through latent variable modeling and optimization AlChE J 70 63 74
16. S Wold N Kettaneh-Wold B Skagerberg 1989 Nonlinear PLS modelling Chemom Intell Lab Syst 7 53 65 10.1016/0169-7439(89)80111-X 1:CAS:528: DyaK3cXhvVKhtLo%3D (Pubitemid 20010594)