Journal of Biopharmaceutical Statistics

The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to such work in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers:Drug, device, and biological research and development Drug screening and drug design Assessment of pharmacological activity Pharmaceutical formulation and scale-up Preclinical safety assessment Bioavailability, bioequivalence, and pharmacokinetics Phase, I, II, and III clinical development Premarket approval assessment of clinical safety Postmarketing surveillance

《生物制药统计》是一本快速发表的杂志，讨论了统计学在生物制药研究和开发中的质量应用。现在每年出版六次，它包括了统计方法论的论述，并以全长和短稿、评论文章、选定/邀请的会议论文、短篇文章和编辑信的形式直接适用于这类作品。该期刊涵盖了对生物统计专业至关重要的及时和挑衅性主题：药物、装置和生物研究与开发药物筛选与药物设计药理活性评价药物配方和扩大规模临床前安全评估生物利用度、生物等效性和药动学I、II和III期临床开发上市前临床安全性评价邮戳监控