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Food and Drug Administration (2004)
Pharmaceutical CGMPs for the 21st
century - A Risk-Based Approach
.
Gad, S.C. (ed.) (2008)
Pharmaceutical Manufacturing Handbook: Regulations
and Quality
. Hoboken, NJ: John Wiley & Sons, Inc.
Herwig, C. and Menezes, J.C. (2013)
The Quality by Design Handbook: A
Systems View on Pharmaceutical and Biopharmaceutical Development and
Manufacturing
. Oxford, UK: Biohealthcare Publishing.
Houson, I. (ed.) (2011)
Process Understanding for Scale-up and Manufacture of
Active Ingredients
. Weinheim, Germany: Wiley-VCH Verlag GmbH & Co.
ICH Topic Q8 (R2) (2009)
Guidance for Industry: Pharmaceutical Development
.
ICH Topic Q9 (2005)
Guidance for Industry: Quality Risk Management
.
ICH Q10 (2007)
Guidance for Industry: Pharmaceutical Quality System
.
ICH Quality IWG (2011)
Points to Consider for ICH Q8/Q9/Q10 Guidelines
.
European Medicines Agency.
Jiang, W. , Kim, S., Zhang, X., Lionberger, R.A., Davit, B.M., et al. (2011) 'The
role of predictive biopharmaceutical modeling and simulation in drug
development and regulatory evaluation',
Int. J. Pharm.
, 418: 151-60.
Korakianiti, E. (2009)
New quality paradigm: Quality by Design ICH Q8-9-10
.
QWP: Quality Assessors Training, October 26-27.
Korakianiti, E. (2011)
Implementation of Quality by Design (QbD) - Current
Perspectives on Opportunities and Challenges. Innovator Industry Perspective.
Regulatory Assessment of Applications Containing QbD Elements: EU
Perspective
. FDA Advisory Committee for Pharmaceutical Science and
Clinical Pharmacology.
Lebrun, P. , Krier, F. , Mantanus, J., Grohganz, H., Yang, M., et al. (2012) 'Design
space approach in the optimization of the spray-drying process',
Eur. J. Pharm.
Biopharm.
, 80: 226-34.
Lionberger, R.A., Lee, S.L., Lee, L.M., Raw, A., and Yu, L.X. (2008) 'Quality by
Design: concepts for ANDAs',
The AAPS J.
, 10(2): 268-76.
Lourenço, V. , Lochmann, D., Reich, G., Menezes, J.C., Herdling, T. , and Schewitz,
J. (2012) 'A Quality by Design study applied to an industrial pharmaceutical
fl uid bed granulation',
Eur. J. Pharm. Biopharm.
, 81: 438-47.
Maltesen, M.J., Bjerregaard, S., Hovgaard, L., Havelund, S., and van de Weert,
M. (2008) 'Quality by Design: spray drying of insulin intended for inhalation',
Eur. J. Pharm. Biopharm.
, 70: 828-38.
Mennini, N., Furlanetto, S., Cirri, M., and Mura, P. (2012) 'Quality by Design
approach for developing chitosan-Ca-alginate microspheres for colon delivery
of celecoxib-hydroxypropyl-ß-cyclodextrin-PVP complex',
Eur. J. Pharm.
Biopharm.
, 80: 67-75.
Migliaccio, G. (2011)
Implementation of Quality by Design (QbD) - Current
Perspectives on Opportunities and Challenges: Innovator Industry Perspective
.
FDA Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology.
Miksinski, S.P. (2011)
Implementation of Quality by Design (QbD) - Current
Perspectives on Opportunities and Challenges. Regulatory Assessment of
Applications Containing QbD Elements - FDA Perspective
. FDA Advisory
Committee for Pharmaceutical Science and Clinical Pharmacology.
Nasr, M.M. (2011)
Implementation of Quality by Design (QbD) - Current
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