Paper Review Records
全部论文审稿周期
25 篇有效样本 · 按发表日期由新到旧排列
审稿天数=录用日期-收稿日期;保留 PDF/DOI/网页源链接
133
天
Safety, Tolerability, and Pharmacokinetics of Oral Camlipixant: A Randomized First‐In‐Human Study Using Single and Multiple Ascending Doses
作者
Nathalie Chauret; Denis Garceau; Laurent Harvey; Zelie Bailes; Elizabeth A. Duncan; Rhian McNaughton; Miren Zamacona展开收起
作者单位
1. Bellus Health Laval Quebec Canada; 2. GSK London UK; 3. GSK Durham North Carolina USA展开收起
73
天
Population Pharmacokinetics and Exposure–Response Analyses of Vepdegestrant, a First‐in‐Class PROteolysis‐TArgeting Chimera Estrogen Receptor Degrader
作者
Derek Z. Yang; Joanna C. Masters; Hechuan Wang; Lana Tran; Yuanyuan Zhang; Kimberly C. Lee; Weiwei Tan; Brian Jermain展开收起
作者单位
1. Pfizer Inc San Diego CA USA; 2. Arvinas Operations, Inc. New Haven CT USA; 3. Pfizer Inc Groton CT USA展开收起
114
天
FDA's Approval Summary of the First Biosimilar to Natalizumab for the Treatment of Multiple Sclerosis and Crohn's Disease
作者
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. Schrieber展开收起
作者单位
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 USA展开收起
70
天
63
天
Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non‐Japanese Individuals
作者
Paridhi Gupta; Ashish Sharma; Bernd Meibohm展开收起
作者单位
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 USA展开收起
84
天
First‐in‐Human Study of a Long‐Acting GLP‐1 Receptor Agonist (TE‐8105) in Overweight or Obese Adults Without Type 2 Diabetes Mellitus
作者
Ya‐Shan Chuang; Jon D. Wright; Mun‐Teng Wong; Kushal J Paneliya; Wei‐Shiung Yang; Hsing‐Mao Chu; Tse Wen Chang; Thomas M Polasek展开收起
作者单位
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 Australia展开收起
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