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010   $a9786613044563
010   $a0-309-15807-9
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100   $a20101215d2010      uy             0
101 0 $aeng
135   $aurcn|||||||||
181   $ctxt
182   $cc
183   $acr
200 00$aRare diseases and orphan products$b[electronic resource] $eaccelerating research and development /$fCommittee on Accelerating Rare Diseases Research and Orphan Product Development, Board on Health Sciences Policy ; Marilyn J. Field and Thomas F. Boat, editors ; Institute of Medicine of the National Academies
210   $aWashington, D.C. $cNational Academies Press$dc2010
215   $a1 online resource (443 p.)
300   $aDescription based upon print version of record.
311   $a0-309-15806-0 
320   $aIncludes bibliographical references (p. 249-282) and index.
327   $a""Front Matter""; ""Acknowledgments""; ""Reviewers""; ""Preface""; ""Contents""; ""Boxes, Figures, and Tables""; ""Summary""; ""1 Introduction""; ""2 Profile of Rare Diseases""; ""3 Regulatory Framework for Drugs for Rare Diseases""; ""4 Discovery Research for Rare Diseases and Orphan Product Development""; ""5 Development of New Therapeutic Drugs and Biologics for Rare Diseases""; ""6 Coverage and Reimbursement: Incentives and Disincentives for Product Development""; ""7 Medical Devices: Research and Development for Rare Diseases""
327   $a""8 Toward an Integrated Approach to Accelerating Research and Product Development for Rare Diseases""""References""; ""Appendix A: Study Activities""; ""Appendix B: Innovation and the Orphan Drug Act, 1983-2009: Regulatory and Clinical Characteristics of Approved Orphan Drugs""; ""Appendix C: Medicare Part D Coverage and Reimbursement of Orphan Drugs""; ""Appendix D: Glossary, Abbreviations, and Public Laws""; ""Appendix E: Rare Diseases Clinical Research Network""; ""Appendix F: Advocacy Group Approaches to Accelerating Research and Product Development: Illustrative Examples""
327   $a""Appendix G: Committee and Staff Biographies""""Index""
606   $aOrphan drugs
606   $aDrugs$xDesign
606   $aRare diseases$xTreatment
608   $aElectronic books.
615  0$aOrphan drugs.
615  0$aDrugs$xDesign.
615  0$aRare diseases$xTreatment.
676   $a615.19
701   $aField$b Marilyn J$g(Marilyn Jane)$0855032
701   $aBoat$b Thomas F$0910464
712 02$aInstitute of Medicine (U.S.).$bCommittee on Accelerating Rare Diseases Research and Orphan Product Development.
712 02$aNational Academies Press (U.S.)
801  0$bMiAaPQ
801  1$bMiAaPQ
801  2$bMiAaPQ
906   $aBOOK
912   $a9910456868603321
996   $aRare diseases and orphan products$92486767
997   $aUNINA