FDA Bioequivalence Standards
Tungkol sa ebook na ito
FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.
Tungkol sa may-akda
Dr. Lawrence X. Yu is the acting director of the Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER), FDA, in Maryland, USA, where he oversees new, generic, and biotechnology product quality review functions as well as the FDA CDER quality labs. Dr. Yu is an adjunct professor at the University of Michigan, a fellow of the American Association of Pharmaceutical Scientists (AAPS) and an associate editor of The AAPS Journal. Dr. Yu received an M.S. in Chemical Engineering from Zhejiang University in Hangzhou, China; an M.S. in Pharmaceutics from the University of Cincinnati in Cincinnati, Ohio, USA; and a Ph.D. in Pharmaceutics from the University of Michigan in Ann Arbor, Michigan, USA. He is also the author/co-author of more than 100 papers, abstracts and book chapters and co-editor of Biopharmaceutics Applications in Drug Development.
Dr. Bing V. Li is a team leader in the Division of Bioequivalence I, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), FDA, in Maryland, USA. Her current responsibility is to review drug products submitted in Abbreviated New Drug Applications (ANDAs) to determine the adequacy of the data from bioequivalence studies based on study design, analytical methodology and statistical analysis. Dr. Li received her Ph.D. in Pharmaceutical Sciences from the University of Wisconsin in Madison, Wisconsin, USA. She has chaired numerous FDA working groups, including the bioequivalence “For-Cause” Inspection, bioequivalence for nasal product review template and population bioequivalence of inhalation products. Dr. Li is also the author/coauthor of 40 papers, abstracts, and book chapters and winner of the Thomas Alva Edison Patent Award.
