Analytical Similarity Assessment in Biosimilar Product Development

About Shein-Chung Chow

AuthorShein-Chung Chow Ph.D is currently an Associate Director at Office ofBiostatistics Center for Drug Evaluation and Research United States Foodand Drug Administration (FDA). Prior to joining FDA Dr. Chow was aProfessor at Duke University School of Medicine Durham NC. He wasalso a special government employee (SGE) appointed by the FDA as anAdvisory Committee member and statistical advisor to the FDA. Prior tothat Dr. Chow also held various positions in the pharmaceutical industrysuch as Vice President at Millennium Cambridge MA Executive Director atCovance Princeton NJ and Director and Department Head at Bristol-MyersSquibb Plainsboro NJ. Dr. Chow is the Editor-in-Chief of the Journal ofBiopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Seriesat Chapman and Hall/CRC Press Taylor & Francis Group. He was electedFellow of the American Statistical Association and an elected member of theISI (International Statistical Institute). Dr. Chow is the author or co-author ofover 300 methodology papers and 29 books including Designs and Analysisof Bioavailability and Bioequivalence Studies Sample Size Calculations in ClinicalResearch Adaptive Design Methods in Clinical Trials Translational MedicineDesign and Analysis of Clinical Trials and Quantitative Methods for TraditionalChinese Medicine Development.