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Generic Drug Product Development: International Regulatory Requirements for Bioequivalence 第1 版
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発送予定日 年11月23日 - 年12月9日
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Generic Drug Product Development: International Regulatory Requirements for Bioequivalence
Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country. This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.
332 pages
| メディア | 書籍 Paperback Book (ソフトカバーで背表紙を接着した本) |
| リリース済み | 2019年9月5日 |
| ISBN13 | 9780367384371 |
| 出版社 | Taylor & Francis Ltd |
| ページ数 | 332 |
| 寸法 | 229 × 152 × 20 mm · 500 g |
| 言語 | 英語 |
| 編集者 | Kanfer, Isadore |
| 編集者 | Shargel, Leon |
