| 书目名称 | The Science and Regulations of Naturally Derived Complex Drugs | | 编辑 | Ram Sasisekharan,Sau L. Lee,Larry A. Walker | | 视频video | | | 概述 | Addresses the regulatory science specific to complex drug products including quality, safety and clinical aspects.Discusses raw materials, manufacturing. quality control, impurities, toxicity, immunog | | 丛书名称 | AAPS Advances in the Pharmaceutical Sciences Series | | 图书封面 |  | | 描述 | This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent | | 出版日期 | Book 2019 | | 关键词 | complex mixtures; toxicity; immunogenicity; drug manufacturing; single agent drug; plant-derived natural | | 版次 | 1 | | doi | https://doi.org/10.1007/978-3-030-11751-1 | | isbn_ebook | 978-3-030-11751-1Series ISSN 2210-7371 Series E-ISSN 2210-738X | | issn_series | 2210-7371 | | copyright | American Association of Pharmaceutical Scientists 2019 |
The information of publication is updating
|
|
发表于 2025-3-21 16:11:44
