Chapter 3: Case Studies: EU Regulatory Guidelines and how to interpret them

Author Jun Wang Chancellor Scholar Duke University School of Medicine About the Author Jun Wang is a Chancellor Scholar of Duke University (North Carolina, USA) and a Ph.D candidate majoring in Pharmacology and Cancer Biology. She has strong interest and expertise in two areas of research: using high-throughput screening and next-generation sequencing to identify novel compounds or biologic products that can be effectively deployed for the treatment of invasive solid tumors; and regulatory requirement and methodology development for the assessment of biosimilar products. She combines her biotechnology background with keen interest in the assessment of biosimilar products. She has been...