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Bioequivalence Requirements in Various Global Jurisdictions. Second Edition 2025
・ISBN 978-3-031-76773-9 hard EUR 199.99
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| 著者・編者 | Kanfer, Isadore (ed.), |
|---|---|
| シリーズ | (AAPS Advances in the Pharmaceutical Sciences Series) |
| 出版社 | (Springer International Publishing AG, SZ) |
| 出版年月 | 2025 |
| ページ数 | 237 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A03-73923＞ |
解説
An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions.
In view of the dynamic nature of regulatory requirements which are usually regularly updated, updating these requirements to remain current is an important necessity to provide such information to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products. The revised volume includes updated information based on recent guidances and guidelines from the respective regulatory agencies as well as important trends and descriptions relating to innovative approaches for bioequivalence assessment.