Paper Review Records
All Paper Review Records
15 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
Four decades of History & Evolution of Clinical Pharmacology at US Food and Drug Administration (FDA)– Part I: Product Quality
AuthorsMehul Mehta
Affiliations1. Division of Neuropsychiatric Products, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USA
Four Decades of History & Evolution of Clinical Pharmacology at US Food and Drug Administration (FDA)—Part II: Dose Individualization and Approvability Evidence
AuthorsMehul Mehta
Affiliations1. Division of Neuropsychiatric Products, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USA
Engineering and Characterisation of 3D-Printed Timolol Maleate Implants for Long-Acting Glaucoma Treatment
AuthorsFebri Annuryanti; Masoud Adhami; Eneko Larrañeta; Lalitkumar Vora; Thakur Raghu Raj Singh
Affiliations1. Faculty of Pharmacy, Universitas Airlangga, Surabaya, Indonesia; 2. McClay Research Centre, Medical Biology Centre, School of Pharmacy, Queen’s University Belfast, Belfast, UK
Verification of a Physiologically-based Pharmacokinetic Model for Predicting CYP3A4-mediated Simvastatin and Simvastatin Acid Drug-drug Interactions
AuthorsBridget L. Morse; Bing Han; Jeffrey J. Alberts; Maria M. Posada; Gemma L. Dickinson; Stephen D. Hall
Affiliations1. Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, USA; 2. Clinical & Quantitative Pharmacology, Vertex Pharmaceuticals, Boston, USA
Exploring a Persistent Terbinafine – CYP2D6 Interaction Using Physiologically – Based Pharmacokinetic Modeling
AuthorsDevendra Pade; Jan Wahlstrom
Affiliations1. Pharmacokinetics and Drug Metabolism, Amgen Inc., Cambridge, USA; 2. Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks, USA
Immunogenicity Assays Used in Support of Marketing Applications of Oligonucleotide Therapeutics
AuthorsCecilia Arfvidsson; Lin-Zhi Chen; Susovan Mohapatra; Kamalika Mukherjee; Pallab Pradhan; Gnana Oli Rajaraman; Arkadeep Sinha; Christopher C. Stebbins; An Zhao; Zhandong Don Zhong; Robert J. Kubiak
Affiliations1. Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, Gothenborg, Sweden; 2. Boehringer Ingelheim Pharmaceuticals, Ridgefield, USA; 3. Stoke Therapeutics, Boston, USA; 4. Regeneron Pharmaceuticals, Tarrytown, USA; 5. AstraZeneca, Gaithersburg, USA; 6. AiCuris Anti-Infective Cures AG, Wuppertal, Germany; 7. Upstream Bio, Waltham, USA; 8. Immunologix Laboratories, Tampa, USA; 9. Denali Therapeutics, South San Francisco, USA; 10. Third Arc Bio, Lower Gwynedd, USA
Dissolution Enhancement by Binding Agents: A Potential Shortcut to Improving Bioavailability?
AuthorsMaja Chronowska; Jennifer Dressman
Affiliations1. Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany; 2. Engelhard Arzneimittel GmbH & Co. KG, Niederdorfelden, Germany; 3. Heraclitus Advisors Pty. Ltd., Melbourne, Australia
In Vitro Release Testing for Long Acting Injectables – a Workshop Summary Report
AuthorsTalia Flanagan; Diane Burgess; Marieta Duvnjak; Nikoletta Fotaki; Kate Harris; Krutika Meena Harish Jain; Dawen Kou; Adam McCartan; Heather Mead; Johanna Milsmann; Randy Mrsny; Vasiliki Paraskevopoulou; Sharadvi Thati; Marta Venczel; David Curran
Affiliations1. UCB Pharma SA, CMC Development Sciences, Braine L’Alleud, Belgium; 2. University of Connecticut, Department of Pharmaceutical Sciences, Storrs, USA; 3. Novartis, Analytical Research & Development, Novartis Pharma AG, Basel, Switzerland; 4. University of Bath, Department of Life Sciences, Claverton Down, UK; 5. AstraZeneca, Global Product Development, Pharmaceutical Technology & Development, Operations, Macclesfield, UK; 6. Gilead Sciences, Analytical Development and Operations, Foster City, USA; 7. Genentech, Synthetic Molecule Pharmaceutical Sciences, South San Francisco, USA; 8. Boehringer Ingelheim Pharma GmbH & Co. KG, Drug Product Development NCE, Biberach, Germany; 9. Bristol Myers Squibb, New Brunswick, USA; 10. Sanofi, Global CMC Development, Sanofi-Aventis Deutschland GmbH, Frankfurt/Main, Germany; 11. GSK, Analytical Development, Collegeville, USA
Immunogenicity in Approved Adeno-Associated Virus-Based Gene Therapies: A Framework for a Tailored Assessment Strategy
AuthorsChing-Ha Lai; Susan C. Irvin; Laura I Salazar-Fontana; Christine Grimaldi; Boris Gorovits; Yuanxin Xu; Michael A. Partridge
Affiliations1. Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc., Tarrytown, United States of America; 2. LAIZ Regulatory Science Consulting Sàrl, Lausanne, Switzerland; 3. Intellia Therapeutics, Cambridge, United States of America
Hand-Held Raman Spectroscopy for Paracetamol Assay in Solution for Infusion: Expanding the Capabilities of Process Analytical Technologies
AuthorsJoão Henriques; Thomas De Beer; Catarina Cardoso; Vera Moura; Carla Vitorino
Affiliations1. Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Coimbra, Portugal; 2. Laboratórios Basi, Parque Industrial Manuel Lourenço Ferreira, Mortágua, Portugal; 3. Basinnov Life Sciences, Unipessoal LDA, Lisbon, Portugal; 4. Laboratory of Pharmaceutical Process Analytical Technology, Department of Analytics, Ghent University, Ghent, Belgium; 5. Coimbra Chemistry Centre, Institute of Molecular Sciences – IMS, Department of Chemistry, University of Coimbra, Coimbra, Portugal
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