Model Based QbD in Drug Substance or Drug Product Conference: AIChE Annual MeetingYear: 2010Proceeding: 2010 AIChE Annual MeetingGroup: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture Type: Oral Room: Grand Ballroom B Location: Salt Palace Convention Center Time: Thursday, November 11, 2010 - 3:15pm-5:45pm Chair(s):Schild, R., Bristol-Myers Squibb Co-chair(s):Nere, N. K., Abbott Laboratories This session invites presentations in which response models have been developed from measured data for operations in drug substance or drug product development. These models may result from statistical design of experiments, a mechanistic / first principles approach, or a combination of the two. Submissions that address model verification are particularly welcome, for example using separate model development and model verification data sets. Papers: 3:15 PM(697a) Computational Predictive Models Applied to Scale-up of Solid Oral Drug ProductsRahul BharadwajPankaj DoshiMary T. Am EndeSalvador Garcia-MunozWilliam R. KetterhagenAndrew Prpich 3:35 PM(697b) Achieving QM Accuracy at a Fraction of Computational Cost: Lattice Energy Minimization of Organic Crystals Containing Highly Flexible MoleculesAndrei V. KazantsevPanagiotis KaramertzanisClaire S. AdjimanConstantinos C. Pantelides 3:55 PM(697c) Applications of Model-Based Quality by Design for Reaction EngineeringStephen A. GuzikowskiJames S. BergumMichael P. CassidyChiajen J. LaiSunil S. PatelMichael E. RandazzoThomas M. RazlerEmily A. ReiffVictor W. RossoJose TaboraJohn E. ThorntonXuejun XuDong Lin 4:15 PM(697d) Mixture DOE and Design SpacePatrick J. WhitcombMark J. Anderson 4:45 PM(697e) A Framework for in-Silico Formulation Design and Optimization Using Multivariate Latent Variable Regression MethodsSalvador Garcia-MunozMark Polizzi 5:05 PM(697f) Modelling and Informatics Challenges IN Film-BASED Drug Formulations and ManufactureMaria Elisa LuqueBo ZhouRodolfo PinalGintaras V. ReklaitisVenkat Venkatasubramanian 5:25 PM(697g) Quality by Design Approach to Pharmacokinetic Modeling. A Case Study On Cyclosporin AEric LueshenCierra HallAndrej MošatAndreas A. Linninger Topics: Particle Technology Physical Properties Checkout Paper abstracts are public but to access Extended Abstracts, you must first purchase the conference proceedings. Checkout Do you already own this? Log In for instructions on accessing this content. Pricing Individuals 2010 Annual Meeting AIChE Members $150.00 AIChE Graduate Student Members Free AIChE Undergraduate Student Members Free Non-Members $225.00 Comprehensive Quality by Design in Pharmaceutical Development and Manufacture only AIChE Members $100.00 AIChE Food, Pharmaceutical & Bioengineering Division Members Free AIChE Graduate Student Members Free AIChE Undergraduate Student Members Free Non-Members $150.00