| 书目名称 | Non-Biological Complex Drugs |
| 副标题 | The Science and the |
| 编辑 | Daan J.A. Crommelin,Jon S. B. de Vlieger |
| 视频video | |
| 概述 | Discusses the challenges of developing NBCDs, recognizing the special position of these products in the regulatory landscape.Reviews analytical tools, pharmacology and PK/PD.Valuable resource for orig |
| 丛书名称 | AAPS Advances in the Pharmaceutical Sciences Series |
| 图书封面 |  |
| 描述 | .The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests..This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table. . |
| 出版日期 | Book 2015 |
| 关键词 | Iron carbohydrate complexes; Liposomes; albumin-cytostatic complexes; glatiramoids; nanomedicines; nanosi |
| 版次 | 1 |
| doi | https://doi.org/10.1007/978-3-319-16241-6 |
| isbn_softcover | 978-3-319-35851-2 |
| isbn_ebook | 978-3-319-16241-6Series ISSN 2210-7371 Series E-ISSN 2210-738X |
| issn_series | 2210-7371 |
| copyright | Springer International Publishing Switzerland 2015 |
发表于 2025-3-21 19:32:32
