期刊介绍：

This rapid publication periodical discusses quality applications of statistics in biopharmaceutical research and development and 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 manufacturing and quality control technical operations regulatory issues.