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The path from biomarker discovery to regulatory qualification /
The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Otros Autores: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam ; Boston :
Academic Press,
�2013.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 019 | |a 857079390 |a 1162223631 | ||
| 020 | |a 9780123944085 |q (electronic bk.) | ||
| 020 | |a 0123944082 |q (electronic bk.) | ||
| 020 | |z 9780123914965 | ||
| 020 | |z 0123914965 | ||
| 035 | |a (OCoLC)854575878 |z (OCoLC)857079390 |z (OCoLC)1162223631 | ||
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| 100 | 1 | |a Goodsaid, Federico. | |
| 245 | 1 | 4 | |a The path from biomarker discovery to regulatory qualification / |c Federico Goodsaid, William B. Mattes. |
| 260 | |a Amsterdam ; |a Boston : |b Academic Press, |c �2013. | ||
| 300 | |a 1 online resource | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 500 | |a Title from PDF title page (viewed on July 29, 2013). | ||
| 500 | |a Includes index. | ||
| 520 | |a The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities. | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a Section 1. Introduction -- section 2. Biomarker development and qualification in the pharmaceutical industry -- section 3. Toxicogenomic biomarkers -- section 4. Biomarkers of drug safety -- section 5. Consortia -- section 6. Path to regulatory qualification process development. | |
| 546 | |a English. | ||
| 650 | 0 | |a Biochemical markers. | |
| 650 | 2 | |a Biomarkers |0 (DNLM)D015415 | |
| 650 | 6 | |a Marqueurs biologiques. |0 (CaQQLa)201-0177920 | |
| 650 | 7 | |a MEDICAL |x Allied Health Services |x Medical Technology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Biotechnology. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Family & General Practice. |2 bisacsh | |
| 650 | 7 | |a MEDICAL |x Lasers in Medicine. |2 bisacsh | |
| 650 | 7 | |a TECHNOLOGY & ENGINEERING |x Biomedical. |2 bisacsh | |
| 650 | 7 | |a Biochemical markers |2 fast |0 (OCoLC)fst00831950 | |
| 655 | 4 | |a Internet Resources. | |
| 700 | 1 | |a Mattes, William B. | |
| 776 | |z 0-12-391496-5 | ||
| 776 | |z 1-299-73889-3 | ||
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9780123914965 |z Texto completo |