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| Document Type: | Book |
|---|---|
| All Authors / Contributors: |
Joanne Hawana; Deborah Runkle |
| ISBN: | 9781935065388 1935065386 |
| OCLC Number: | 773372180 |
| Notes: | "Published by the Food and Drug Law Institute in partnership with the American Association for the Advancement of Science (AAAS)"--P. 4 of cover. |
| Description: | xxx, 324 p. : ill. ; 26 cm. |
| Contents: | Scientific domains of personalized medicine / Jeffrey Jackson ... [et al.] -- Critical role of biomarkers in personalized healthcare / Klaus Lindpaintner -- Personalized medicine in the clinic / Marc S. Williams -- Ethics and personalized medicine / Ellen Wright Clayton -- Public policy considerations : Shaping the future for personalized healthcare / Gregory J. Downing -- Educational challenges associated with personalized medicine / Neil E. Lamb and Adam M. Hott -- Considerations in personalized medicine R&D / Jamie K. Wolszon -- Reimbursement for personalized medicine / Gail Daubert, Paul Sheives and Joe Metro. Appx. A: Guidance for industry - Clinical Pharmacogenomics: Premarketing evaluation in early phase clinical studies -- Appx. B: Draft guidance for industry, clinical laboratories, and FDA staff - in vitro diagnostic multivariate index assays -- Appx. C: Genomics translation -- Appx. D: Decision memo for pharmacogenomic testing for warfarin response (CAG-00400N) -- Appx. E: Guidance for industry and FDA staff - Commercially distributed analyte specific reagents (ASRs): Frequently asked questions -- Appx. F: Guidance for industry and FDA staff - Pharmacogenetic tests and genetic tests for heritable markers. |
| Responsibility: | edited by Joanne Hawana and Deborah Runkle. |
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