Journal of Biopharmaceutical Statistics

期刊简介：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 biopharmaceutical research 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 including complex innovative designs;Premarket approval assessment of clinical safety;Postmarketing surveillance;Big data and artificial intelligence and applications.

【译文】这是一本快速出版的生物制药统计学期刊，讨论了在生物制药研究和开发中统计学的质量应用。现在每年出版六次，包括全文和简短的手稿、综述文章、精选/邀请的会议论文、短文和编辑信件等形式，展示了具有即时应用性的统计方法。该期刊涵盖了：药物、设备和生物研究开发；药物筛选和药物设计；药理活性评估；制药配方和放大；临床前安全性评估；生物利用度、生物等效性和药代动力学；I、II、III期临床试验，包括复杂创新设计；临床前安全性审批评估；上市后监测；大数据和人工智能及其应用。