FDA/M-CERSI Co-Processed API Workshop Proceedings.

[1]  A. Florence,et al.  A Unified AI Framework for Solubility Prediction Across Organic Solvents , 2023, Digital Discovery.

[2]  J. Rowe,et al.  Densifying Co-Precipitated Amorphous Dispersions to Achieve Improved Bulk Powder Properties. , 2022, Pharmaceutical research.

[3]  Cameron J. Brown,et al.  Comparative Studies of Powder Flow Predictions Using Milligrams of Powder for Identifying Powder Flow Issues. , 2022, International journal of pharmaceutics.

[4]  J. Rowe,et al.  High bulk-density amorphous dispersions to enable direct compression of reduced tablet size amorphous dosage units. , 2022, Journal of Pharmacy and Science.

[5]  A. Sheikh,et al.  Origins and Implications of Extraordinarily Soft Crystals in a Fixed-Dose Combination Hepatitis C Regimen , 2022, Crystal Growth & Design.

[6]  S. Ferguson,et al.  Integrated Purification and Formulation of an Active Pharmaceutical Ingredient via Agitated Bed Crystallization and Fluidized Bed Processing , 2022, Pharmaceutics.

[7]  Luke Schenck,et al.  Coprecipitated Amorphous Dispersions as Drug Substance: Opportunities and Challenges , 2021, Organic Process Research & Development.

[8]  Ahmad Y. Sheikh,et al.  Distinct Hybrid Hydrates of Paritaprevir: Combined Experimental and Computational Assessment of their Hydration–Dehydration Behavior and Implications for Regulatory Controls , 2021, Crystal Growth & Design.

[9]  Yongchao Su,et al.  Optimizing Solvent Selection and Processing Conditions to Generate High Bulk-Density, Co-Precipitated Amorphous Dispersions of Posaconazole , 2021, Pharmaceutics.

[10]  Ahmad Y. Sheikh,et al.  Implications of the Conformationally Flexible, Macrocyclic Structure of the First-Generation, Direct-Acting Anti-Viral Paritaprevir on Its Solid Form Complexity and Chameleonic Behavior. , 2021, Journal of the American Chemical Society.

[11]  J. Beierle,et al.  The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management. , 2021, Journal of pharmaceutical sciences.

[12]  P. McArdle,et al.  Factors Controlling Persistent Needle Crystal Growth: The Importance of Dominant One-Dimensional Secondary Bonding, Stacked Structures, and van der Waals Contact , 2021, Crystal growth & design.

[13]  S. Ferguson,et al.  Formulation of ionic liquid APIs via spray drying processes to enable conversion into single and two-phase solid forms. , 2021, International journal of pharmaceutics.

[14]  Alessandra Mattei,et al.  Novel Physics-Based Ensemble Modeling Approach That Utilizes 3D Molecular Conformation and Packing to Access Aqueous Thermodynamic Solubility: A Case Study of Orally Available Bromodomain and Extraterminal Domain Inhibitor Lead Optimization Series , 2021, J. Chem. Inf. Model..

[15]  Christopher J Testa,et al.  Heterogeneous Crystallization as a Process Intensification Technology in an Integrated Continuous Manufacturing Process for Pharmaceuticals , 2021, Organic Process Research & Development.

[16]  D. Croker,et al.  Manipulating Cocrystal Size and Morphology using a Combination of Temperature Cycling and Additives , 2020 .

[17]  Jianhong Yang,et al.  Prediction of the physical stability of amorphous solid dispersions: relationship of aging and phase separation with the thermodynamic and kinetic models along with characterization techniques , 2020, Expert Opinion on Drug Delivery.

[18]  M. Capece,et al.  Improving the effectiveness of the Comil as a dry-coating process: Enabling direct compaction for high drug loading formulations , 2020 .

[19]  S. Ferguson,et al.  Spray Encapsulation as a Formulation Strategy for Drug-Based Room Temperature Ionic Liquids: Exploiting Drug-Polymer Immiscibility to Enable Processing for Solid Dosage Forms. , 2020, Molecular pharmaceutics.

[20]  D. Mcginnity,et al.  Optimising proteolysis-targeting chimeras (PROTACs) for oral drug delivery: a drug metabolism and pharmacokinetics perspective. , 2020, Drug discovery today.

[21]  Luke Schenck,et al.  Recent Advances in Co-Processed APIs and Proposals for Enabling Commercialization of These Transformative Technologies. , 2020, Molecular pharmaceutics.

[22]  P. McArdle,et al.  Unprecedented morphology control of gas phase cocrystal growth using multi zone heating and tailor made additives. , 2020, Chemical communications.

[23]  Asher Mullard,et al.  2019 FDA drug approvals , 2020, Nature Reviews Drug Discovery.

[24]  Ahmad Y. Sheikh,et al.  Process development of ABT-450 – A first generation NS3/4A protease inhibitor for HCV , 2019, Tetrahedron.

[25]  Bin Yang,et al.  Proteolysis targeting chimeras (PROTACs) in 'beyond rule-of-five' chemical space: Recent progress and future challenges. , 2019, Bioorganic & medicinal chemistry letters.

[26]  Blair F. Johnston,et al.  A random forest model for predicting crystal packing of olanzapine solvates , 2018 .

[27]  N. Meanwell,et al.  The expanding role of prodrugs in contemporary drug design and development , 2018, Nature Reviews Drug Discovery.

[28]  M. Wendt,et al.  Beyond the Rule of 5: Lessons Learned from AbbVie's Drugs and Compound Collection. , 2017, Journal of medicinal chemistry.

[29]  Christopher J. Testa,et al.  Continuous Heterogeneous Crystallization on Excipient Surfaces , 2017 .

[30]  S. Vajda,et al.  Quantifying the chameleonic properties of macrocycles and other high-molecular-weight drugs. , 2016, Drug discovery today.

[31]  Carl J. Tilbury,et al.  Predicting the Effect of Solvent on the Crystal Habit of Small Organic Molecules , 2016 .

[32]  Bradley C Doak,et al.  How Beyond Rule of 5 Drugs and Clinical Candidates Bind to Their Targets. , 2016, Journal of medicinal chemistry.

[33]  Erik Schultes,et al.  The FAIR Guiding Principles for scientific data management and stewardship , 2016, Scientific Data.

[34]  K. Sirkar,et al.  Continuous preparation of polymer coated drug crystals by solid hollow fiber membrane-based cooling crystallization. , 2016, International journal of pharmaceutics.

[35]  M. Capece,et al.  Prediction of powder flow performance using a multi-component granular Bond number , 2015 .

[36]  Blair F. Johnston,et al.  A random forest model for predicting the crystallisability of organic molecules , 2015 .

[37]  K. Sirkar,et al.  Continuous Polymer Coating/Encapsulation of Submicrometer Particles Using a Solid Hollow Fiber Cooling Crystallization Method , 2014 .

[38]  T. Blundell,et al.  Structural biology and drug discovery of difficult targets: the limits of ligandability. , 2012, Chemistry & biology.

[39]  Changquan Calvin Sun,et al.  Profoundly improving flow properties of a cohesive cellulose powder by surface coating with nano-silica through comilling. , 2011, Journal of pharmaceutical sciences.

[40]  Rajesh N. Dave,et al.  Dry particle coating for improving the flowability of cohesive powders , 2005 .

[41]  Kamalesh K. Sirkar,et al.  Solid Hollow Fiber Cooling Crystallization , 2004 .