株式会社極東書店トップ ＞ 商品一覧 ＞ The Pharmaceutical Regulatory Process. 2nd edition
商品詳細
The Pharmaceutical Regulatory Process. 2nd edition
・ISBN 978-1-138-38128-5 paper GB£ 68.99
￥21,855.- (税込) ※（※）価格はご注文時の参考価格となります。
納品価格につきましては書籍の入荷時点で確定となります。
版元の原価改定、外国為替の変動等により異なる場合がございますので、予めご了承下さい。
| 著者・編者 | Berry, Ira R. / Martin, Robert P. (eds.), |
|---|---|
| シリーズ | (Drugs and the Pharmaceutical Sciences) |
| 出版社 | (CRC Press, UK) |
| 出版年月 | 2019 |
| ページ数 | 492 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A01-29676＞ |
解説
This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.
New chapters cover:
- the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance
- pharmacovigilance programs designed to prevent widespread safety issues
- legal issues surrounding the sourcing of foreign APIs
- the issues of counterfeit drugs
- updates on quality standards