| 書名 | 作者 | 出版年 | 查看 | 回報錯誤連結 |
|---|
| Orphan drugs:understanding the rare disease market and its dynamics / |
E. Hernberg-Ståhl and M. Reljanović. |
2013 |
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|
回報問題連結 |
| New drug approval process:global challenges and solutions / |
Richard Guarino. |
2009 |
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|
回報問題連結 |
| Pharmaceutical pre-approval inspections:a guide to regulatory success / |
Martin D. Hynes III. |
2008 |
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|
回報問題連結 |
| Clinical trials:study design, endpoints and biomarkers, drug safety, FDA and ICH guidelines / |
Tom Brody. |
2012 |
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|
回報問題連結 |
| Off-label prescribing:justifying unapproved medicine / |
David Cavalla. |
2015 |
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|
回報問題連結 |
| Generic drug product development:solid oral dosage forms / |
Leon Shargel, Isadore Kanfer. |
2014 |
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|
回報問題連結 |
| Safety pharmacology in pharmaceutical development:approval and post marketing surveillance / |
Shayne C. Gad. |
2012 |
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|
回報問題連結 |
| FDA regulatory affairs |
David Mantus, Douglas J. Pisano. |
2014 |
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|
回報問題連結 |
| FDA regulatory affairs:a guide for prescription drugs, medical devices, and biologics / |
Douglas J. Pisano, David S. Mantus. |
2008 |
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回報問題連結 |
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