Dr. Donald J. Schuirmann is a preeminent mathematical statistician renowned for his transformative contributions to regulatory science and pharmaceutical statistics. He currently serves as an Expert Mathematical Statistician within the Division of Biometrics VIII, Office of Biostatistics at the Center for Drug Evaluation and Research, U.S. Food and Drug Administration. With a distinguished career spanning over three decades at the FDA, Dr. Schuirmann has established himself as a leading authority in bioequivalence assessment methodology, bringing rigorous statistical approaches to critical regulatory questions. His foundational work has shaped the scientific framework for evaluating generic drug products, ensuring therapeutic equivalence while maintaining scientific integrity in regulatory decision-making processes.
Dr. Schuirmann's seminal contribution to the field is the development and refinement of the two one-sided tests procedure, which has become the gold standard for assessing average bioequivalence in generic drug development. His pioneering work on Reference Scaled Average Bioequivalence methodology provided scientifically justified approaches for evaluating Highly Variable Drugs and Narrow Therapeutic Index products, addressing complex statistical challenges that previously hindered generic drug development. His research has directly informed multiple FDA guidance documents, including the Draft Guidance on Warfarin Sodium, establishing rigorous statistical criteria that balance patient safety with therapeutic efficacy. These methodological innovations have enabled more accurate assessment of drug products while maintaining appropriate statistical rigor, significantly impacting regulatory science worldwide.
Beyond his technical contributions, Dr. Schuirmann has played a pivotal role in international harmonization efforts through his active participation in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, particularly in the M13 Expert Working Group. His recent work proposing alternative bioequivalence criteria for Narrow Therapeutic Index drugs demonstrates his continued leadership in advancing regulatory science to address evolving pharmaceutical challenges. As a respected authority, his statistical methodologies have been adopted by regulatory agencies globally, establishing common scientific standards that facilitate international drug development and approval. Dr. Schuirmann remains at the forefront of pharmaceutical statistics, guiding the development of next-generation bioequivalence assessment methods that will continue to shape regulatory science for future generations of therapeutic products.
