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.
An In Vitro Quantitative Systems Pharmacology Platform for Characterizing CD3-Bispecific Antibody-Mediated T-Cell Activation and Tumor Cell Cytotoxicity
AuthorsXuanzhen Yuan; Craig Thalhauser; Nasrin Afzal; Kristel Kemper; Guohua An; Tommy Li
Affiliations1. Department of Pharmaceutical Sciences and Experimental Therapeutics, College of Pharmacy, University of Iowa, Iowa City, USA; 2. Genmab, Princeton, USA
Assessment of Sorbitol as a Pharmaceutical Excipient in Oral Liquid Pediatric Formulations Submitted to the U.S. FDA
AuthorsGelareh A. Abulwerdi; Brianna Cote; Susan Abdel-Rahman; Elimika Pfuma Fletcher; Gilbert J. Burckart
Affiliations1. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, USA
Calculating Receptor Occupancy using TMDD Models – What has to be Considered?
AuthorsYu Fu; Liang Yang; Hong Su; Ye Yao; Yu Li; Peiming Ma
Affiliations1. Development Science, AstraZeneca R&D, Shanghai, China; 2. Xiangya School of Pharmaceutical Sciences, Central South University, Changsha, China
Updated Recommendations for the Bioanalysis of Antibody–Drug Conjugates (ADC) from the ADC working group of the AAPS Bioanalytical Community
AuthorsJim X. Shen; Robert Dodge; Shoshana Oberstein; Jennifer Cunliffe; Varun Ramani; Soumya Mohana Sundaram; Ines C. Santos; Chongwoo Yu; Sanjay L. Dholakiya; Seema Kumar; Xiaohui Sophia Xu; Sasha Fraser; Zeinab Mokhtari; Feng Yin; David G. Rizzo; Omar S. Barnaby; Honglue Shen; Dominic E. Warrino; Shivangi Awasthi; Krista Burke; Stephanie Schaffer; Alok Rathi
Affiliations1. Bristol Myers Squibb, Lawrenceville, USA; 2. Princeton, USA; 3. Takeda Pharmaceutical Company Limited, Tokyo, Japan; 4. Novartis, Cambridge, USA; 5. Celerion, Lincoln, USA; 6. US Food and Drug Administration, Silver Spring, USA; 7. Pioneering Medicines at Flagship Pioneering Inc., Cambridge, USA; 8. Daiichi Sankyo Inc., Basking Ridge, USA; 9. Regeneron Pharmaceuticals Inc., Tarrytown, USA; 10. AbbVie Inc., North Chicago, Illinois, USA; 11. Amgen, USA; 12. Merck & Co., Inc., Rahway, USA; 13. KCAS Bio, Olathe, USA; 14. New Brunswick, USA; 15. BioAgilytix Boston, Boston, USA
In vivo Predictive Dissolution Test Using Biorelevant Bicarbonate Buffer for High-dose Free Acid Drug
AuthorsYuki Tarumi; Kiyohiko Sugano
Affiliations1. Molecular Pharmaceutics Lab., College of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, Japan
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