Generic Drug Product Development pdf epub mobi txt 电子书 下载 2025
- understand
- if
- can
- Product
- I
- Generkc
- Drug
- Development
- 仿制药
- 药物开发
- 制剂学
- 药物分析
- 质量控制
- 法规
- 临床试验
- 药物化学
- 药代动力学
- 生物利用度
具体描述
Generic Drug Product Development: Specialty Dosage Forms explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. In addition, the book provides various scientific approaches and regulatory requirements for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. This book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products. The book will be of interest of specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.
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