Paper Review Records
All Paper Review Records
25 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
133
days
Safety, Tolerability, and Pharmacokinetics of Oral Camlipixant: A Randomized First‐In‐Human Study Using Single and Multiple Ascending Doses
Authors
Nathalie Chauret; Denis Garceau; Laurent Harvey; Zelie Bailes; Elizabeth A. Duncan; Rhian McNaughton; Miren ZamaconaShow moreShow less
Affiliations
1. Bellus Health Laval Quebec Canada; 2. GSK London UK; 3. GSK Durham North Carolina USAShow moreShow less
73
days
Population Pharmacokinetics and Exposure–Response Analyses of Vepdegestrant, a First‐in‐Class PROteolysis‐TArgeting Chimera Estrogen Receptor Degrader
Authors
Derek Z. Yang; Joanna C. Masters; Hechuan Wang; Lana Tran; Yuanyuan Zhang; Kimberly C. Lee; Weiwei Tan; Brian JermainShow moreShow less
Affiliations
1. Pfizer Inc San Diego CA USA; 2. Arvinas Operations, Inc. New Haven CT USA; 3. Pfizer Inc Groton CT USAShow moreShow less
114
days
FDA's Approval Summary of the First Biosimilar to Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease
Authors
Poonam R. Delvadia; Anantha Ram Nookala; Gopichand Gottipati; Sreedharan Sabarinath; Ramana S. Uppoor; Mehul U. Mehta; Xiulian Du; Yow‐Ming C. Wang; Milos Dokmanovic; Riley Myers; Jessica Stevens; Laura Baldassari; Paul Lee; Laura Jawidzik; Sandhya Apparaju; Suna Seo; Nina N. Brahme; Sarah J. SchrieberShow moreShow less
Affiliations
1. Division of Neuropsychiatric Pharmacology Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USA; 2. Therapeutic Biologics Program Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USA; 3. Division of Product Quality Assessment XIII Office of Product Quality Assessment III Office of Pharmaceutical Quality Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USA; 4. National Institute for Innovation in Manufacturing Biopharmaceuticals University of Delaware Newark DE USA; 5. Division of Neurology II Office of Neuroscience Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USA; 6. Clintrex Research LLC A BlueRidge Life Sciences Company Houston TX USA; 7. Division of Gastroenterology Office of Immunology and Inflammation Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USA; 8. Science Review Staff Office of Therapeutic Biologics and Biosimilars Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration Silver Spring MD USAShow moreShow less
70
days
From Small Data to Big Decisions: How Clinical Pharmacology Shapes Rare Disease Development
Authors
Yan Xu; Alissa Verone‐Boyle; Natalie Schmitz; Hamim Zahir; Brian A. WillisShow moreShow less
Affiliations
1. Clinical Pharmacology and Pharmacometrics, Biogen Cambridge MA USAShow moreShow less
63
days
Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non‐Japanese Individuals
Authors
Paridhi Gupta; Ashish Sharma; Bernd MeibohmShow moreShow less
Affiliations
1. Department of Pharmaceutical Sciences College of Pharmacy University of Tennessee Health Science Center Memphis TN USA; 2. Clinical Pharmacology Boehringer Ingelheim Pharmaceuticals Ridgefield CT USAShow moreShow less
84
days
First‐in‐Human Study of a Long‐Acting GLP‐1 Receptor Agonist (TE‐8105) in Overweight or Obese Adults Without Type 2 Diabetes Mellitus
Authors
Ya‐Shan Chuang; Jon D. Wright; Mun‐Teng Wong; Kushal J Paneliya; Wei‐Shiung Yang; Hsing‐Mao Chu; Tse Wen Chang; Thomas M PolasekShow moreShow less
Affiliations
1. Immunwork, Inc. Taipei City Taiwan; 2. CMAX Clinical Research Pty Ltd Adelaide Australia; 3. Department of Internal Medicine National Taiwan University Hospital Taipei City Taiwan; 4. T‐E Meds, Inc. Taipei City Taiwan; 5. Centre for Medicine Use and Safety Monash University Melbourne AustraliaShow moreShow less
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