Paper Review Records
All Paper Review Records
20 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
139
days
In Vitro Release Testing for Long Acting Injectables – a Workshop Summary Report
Authors
Talia 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 CurranShow moreShow less
Affiliations
1. 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, USAShow moreShow less
178
days
Immunogenicity in Approved Adeno-Associated Virus-Based Gene Therapies: A Framework for a Tailored Assessment Strategy
Authors
Ching-Ha Lai; Susan C. Irvin; Laura I Salazar-Fontana; Christine Grimaldi; Boris Gorovits; Yuanxin Xu; Michael A. PartridgeShow moreShow less
Affiliations
1. 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 AmericaShow moreShow less
151
days
Hand-Held Raman Spectroscopy for Paracetamol Assay in Solution for Infusion: Expanding the Capabilities of Process Analytical Technologies
Authors
João Henriques; Thomas De Beer; Catarina Cardoso; Vera Moura; Carla VitorinoShow moreShow less
Affiliations
1. 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, PortugalShow moreShow less
99
days
An In Vitro Quantitative Systems Pharmacology Platform for Characterizing CD3-Bispecific Antibody-Mediated T-Cell Activation and Tumor Cell Cytotoxicity
Authors
Xuanzhen Yuan; Craig Thalhauser; Nasrin Afzal; Kristel Kemper; Guohua An; Tommy LiShow moreShow less
Affiliations
1. Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, Iowa City, USA; 2. Genmab, Princeton, USAShow moreShow less
100
days
Assessment of Sorbitol as a Pharmaceutical Excipient in Oral Liquid Pediatric Formulations Submitted to the U.S. FDA
Authors
Gelareh A. Abulwerdi; Brianna Cote; Susan Abdel-Rahman; Elimika Pfuma Fletcher; Gilbert J. BurckartShow moreShow less
Affiliations
1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USAShow moreShow less
153
days
Calculating Receptor Occupancy using TMDD Models – What has to be Considered?
Authors
Yu Fu; Liang Yang; Hong Su; Ye Yao; Yu Li; Peiming MaShow moreShow less
Affiliations
1. Development Science, AstraZeneca R&D, Shanghai, China; 2. Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, ChinaShow moreShow less
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