Q8(R2): Pharmaceutical Development

[1]  K R Morris,et al.  Selection of solid dosage form composition through drug-excipient compatibility testing. , 1999, Journal of pharmaceutical sciences.

[2]  Lawrence X. Yu.  Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control , 2008, Pharmaceutical Research.

[3]  M. Kuentz,et al.  Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[4]  G. K. Raju,et al.  Understanding Pharmaceutical Quality by Design , 2014, The AAPS Journal.

[5]  Gavin K. Reynolds,et al.  Practical application of roller compaction process modeling , 2010, Comput. Chem. Eng..

[6]  P. Kleinebudde.  Roll compaction/dry granulation: pharmaceutical applications. , 2004, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[7]  Matthew Howard,et al.  Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm , 2014, AAPS PharmSciTech.

[8]  R. J. Hintz,et al.  The effect of particle size distribution on dissolution rate and oral absorption , 1989 .

[9]  J. Macgregor,et al.  Scale-up of a Pharmaceutical Roller Compaction Process Using a Joint-Y Partial Least Squares Model , 2011 .

[10]  Johannes I.M. Halman,et al.  Platform driven development of product families: Linking theory with practice , 2001 .

[11]  Hong Wen,et al.  Systematical approach of formulation and process development using roller compaction. , 2009, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[12]  Keith McDonald,et al.  ICH Q11: development and manufacture of drug substances–chemical and biotechnological/biological entities , 2012 .

[13]  R. Pinal,et al.  Utility of Multivariate Analysis in Modeling the Effects of Raw Material Properties and Operating Parameters on Granule and Ribbon Properties Prepared in Roller Compaction , 2008 .

[14]  Sarfaraz Niazi,et al.  Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products , 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

[15]  Pedro Hernandez-Abad,et al.  Quality by design case study: an integrated multivariate approach to drug product and process development. , 2009, International journal of pharmaceutics.

[16]  Hu Zhang,et al.  Quality by design for biopharmaceuticals: a historical review and guide for implementation , 2013 .

[17]  Niels Henrik Mortensen,et al.  IMPLEMENTING PRODUCT PLATFORMS: A CASE STUDY , 2006 .

[18]  M. Khan,et al.  Optimization of a self-nanoemulsified tablet dosage form of Ubiquinone using response surface methodology: effect of formulation ingredients. , 2002, International journal of pharmaceutics.

[19]  Sanjay Garg,et al.  Selection of excipients for extended release formulations of glipizide through drug-excipient compatibility testing. , 2005, Journal of pharmaceutical and biomedical analysis.

[20]  A. Noyes,et al.  The rate of solution of solid substances in their own solutions , 1897 .

[21]  J. Kushner,et al.  A quality-by-design study for an immediate-release tablet platform: examining the relative impact of active pharmaceutical ingredient properties, processing methods, and excipient variability on drug product quality attributes. , 2014, Journal of pharmaceutical sciences.

[22]  Sarfaraz K. Niazi,et al.  Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances , 2016, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.

[23]  Gregory A. Sacha,et al.  Pre-filled syringes: a review of the history, manufacturing and challenges , 2015, Pharmaceutical development and technology.

[24]  M. Khan,et al.  Quality by design: impact of formulation variables and their interactions on quality attributes of a lyophilized monoclonal antibody. , 2012, International journal of pharmaceutics.

[25]  John J. Peterson,et al.  The ICH Q8 Definition of Design Space: A Comparison of the Overlapping Means and the Bayesian Predictive Approaches , 2010 .