Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development Journal title: The AAPS Journal Authors: Xinyuan Zhang, Robert A. Lionberger, Barbara M. Davit, Lawrence X. Yu Subject(s): Medicine
Dissolution Testing for Generic Drugs: An FDA Perspective Journal title: The AAPS Journal Authors: Om Anand, Lawrence X. Yu, Dale P. Conner, Barbara M. Davit Subject(s): Medicine
Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit Journal title: The AAPS Journal Authors: Arzu Selen, Maria T. Cruañes, Anette Müllertz, Paul A. Dickinson, Jack A. Cook, Jame... Subject(s): Medicine
Isothermal Microcalorimetry as a Quality by Design Tool to Determine Optimal Blending Sequences Journal title: The AAPS Journal Authors: M. H. D. Kamal Al-Hallak, Shirzad Azarmi, Zhenghe Xu, Yadollah Maham, Raimar Löbenberg Subject(s): Medicine
Investigation of the Performance of the Disintegration Test for Dietary Supplements Journal title: The AAPS Journal Authors: May Almukainzi, Mahnor Salehi, Nadia Araci Bou-Chacra, Raimar Löbenberg Subject(s): Medicine
Quality by Design: Concepts for ANDAs Journal title: The AAPS Journal Authors: Robert A. Lionberger, Sau Lawrence Lee, LaiMing Lee, Andre Raw, Lawrence X. Yu Subject(s): Medicine
Clinical Relevance of Dissolution Testing in Quality by Design Journal title: The AAPS Journal Authors: Paul A. Dickinson, Wang Wang Lee, Paul W. Stott, Andy I. Townsend, John P. Smart, Parviz Ghahramani,... Subject(s): Medicine
Physiologically Based Absorption Modelling to Predict the Impact of Drug Properties on Pharmacokinetics of Bitopertin Journal title: The AAPS Journal Authors: Neil Parrott, Dominik Hainzl, Emmanuel Scheubel, Siegfried Krimmer, Christophe Boetsch, Elena Guerin... Subject(s): Medicine
Understanding Pharmaceutical Quality by Design Journal title: The AAPS Journal Authors: Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, Janet Woo... Subject(s): Medicine
A Novel Beads-Based Dissolution Method for the In Vitro Evaluation of Extended Release HPMC Matrix Tablets and the Correlation with the In Vivo Data Journal title: The AAPS Journal Authors: Uroš Klančar, Boštjan Markun, Saša Baumgartner, Igor Legen Subject(s): Medicine
Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products Journal title: The AAPS Journal Authors: Rong-Kun Chang, Andre Raw, Robert Lionberger, Lawrence Yu Subject(s): Medicine
Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation Journal title: AAPS PharmSciTech Authors: Hemlata Patil, Roshan V. Tiwari, Michael A. Repka Subject(s): Medicine
A Quality by Experimental Design Approach to Assess the Effect of Formulation and Process Variables on the Extrusion and Spheronization of Drug-Loaded Pellets Containing Polyplasdone® XL-10 Journal title: AAPS PharmSciTech Authors: Kalyan K. Saripella, Nikhil C. Loka, Rama Mallipeddi, Anuja M. Rane, Steven H. Neau Subject(s): Medicine
QbD-Enabled Development of Novel Stimuli-Responsive Gastroretentive Systems of Acyclovir for Improved Patient Compliance and Biopharmaceutical Performance Journal title: AAPS PharmSciTech Authors: Bhupinder Singh, Anterpreet Kaur, Shashi Dhiman, Babita Garg, Rajneet Kaur Khurana, Sarwar Beg Subject(s): Medicine
A Risk-Based Approach to Management of Leachables Utilizing Statistical Analysis of Extractables Journal title: AAPS PharmSciTech Authors: Cheryl L. M. Stults, Jaromir Mikl, Oliver Whelehan, Bradley Morrical, William Duffield, Lee M. Nagao Subject(s): Medicine
