1.

Record Nr.

UNINA9910791477303321

Titolo

Evaluation of biomarkers and surrogate endpoints in chronic disease [[electronic resource] /] / Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Board on Health Care Services, Board on Health Sciences Policy, Food and Nutrition Board, Institute of Medicine ; Christine M. Micheel and John R. Ball, editors

Pubbl/distr/stampa

Washington, DC, : National Academies Press, c2010

ISBN

0-309-15727-7

1-282-78742-X

9786612787423

0-309-15130-9

Descrizione fisica

1 online resource (335 p.)

Altri autori (Persone)

MicheelChristine

BallJohn <1944->

Disciplina

610.28

Soggetti

Biochemical markers - Evaluation

Chronic diseases

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references.

Nota di contenuto

""Front Matter""; ""Reviewers""; ""Preface""; ""Acknowledgments""; ""Contents""; ""Boxes, Figures, and Tables""; ""Summary""; ""1 Introduction""; ""2 Review: Evaluating and Regulating Biomarker Use""; ""3 The Biomarker Evaluation Process""; ""4 Case Studies""; ""5 Strengthening Evidence-Based Regulation""; ""Acronyms""; ""Glossary""; ""Appendix A: Table of Papers About Biomarker Qualification""; ""Appendix B: Recommendations from Related IOM Reports""; ""Appendix C: Committee Member and Consultant Biographies""; ""Appendix D: Staff Biographies""; ""Appendix E: Workshop Agenda""

""Appendix F: Speaker Biographies""

Sommario/riassunto

"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent



process."--Publisher's description.