Nonclinical development of novel biologics biosimilars vaccines and specialty biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals biosimilars vaccines cell and gene therapies and blood products this book compares and contrasts these types of biologics with one another and with small molecule drugs while incorporating the most current and essential international regulatory documents. Nonclinical development of novel biologics biosimilars vaccines and specialty biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals biosimilars vaccines cell and gene therapies and blood products this book compares and contrasts these types of biologics with one another and with small molecule drugs while incorporating the most current and essential international regulatory documents. Nonclinical development of novel biologics biosimilars vaccines and specialty biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals . Nonclinical development of novel biologics biosimilars vaccines and specialty biologics edited by lisa m plitnick ms phd and danuta j herzyk phd merck research laboratories merck co inc west point pa usa elsevier amsterdam o boston o heidelberg o london new york o oxford o paris o san diego. Nonclinical lead for the successful nda bla filings for a monoclonal antibody a biosimilar and a vaccine dr plitnick is co editor of a book entitled nonclinical development of novel biologics biosimilars vaccines and specialty biologics and has written and or contributed to book chapters on