Development of FDA-regulated medical products :: a translational approach /
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Milwaukee, Wisconsin :
ASQ Quality Press,
2012.
|
| Ausgabe: | Second edition. |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Beschreibung: | 1 online resource (255 pages) : illustrations |
| Bibliographie: | Includes bibliographical references and index. |
| ISBN: | 9780873898331 0873898338 6000049358 9786000049355 |
Internformat
MARC
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| 245 | 1 | 0 | |a Development of FDA-regulated medical products : |b a translational approach / |c Elaine Whitmore. |
| 250 | |a Second edition. | ||
| 264 | 1 | |a Milwaukee, Wisconsin : |b ASQ Quality Press, |c 2012. | |
| 300 | |a 1 online resource (255 pages) : |b illustrations | ||
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| 504 | |a Includes bibliographical references and index. | ||
| 588 | 0 | |a Print version record. | |
| 546 | |a English. | ||
| 505 | 0 | |a Intro -- Table of Contents -- List of Figures and Tables -- Acronyms and Abbreviations -- Preface -- Part I Unique Challenges in Medical Product Development -- 1 Pushing the Pipeline -- 2 Healthcare in the United States -- 3 It's Not Your Father's FDA -- 4 Classifying Medical Products -- 5 Product Liability and Product Development -- Part II Bringing a New Medical Product to Market -- 6 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices -- 7 Quality by Design -- 8 Designing-Out Disaster: Risk Analysis -- 9 Recalls, Withdrawals, and Revocations -- 10 Human Factors and Usability Engineering -- 11 Is It Safe and Does It Work? -- 12 How Much Is the Product Really Worth? -- Part III Product Development Planning -- 13 Models and Metaphors -- 14 Components of Product Development Planning -- 15 Components of Product Development Planning -- 16 Components of Product Development Planning -- 17 Components of Product Development Planning -- 18 Better Double-Check That -- 19 Where Do We Go From Here? -- Appendix Resources -- Endnotes -- Glossary -- Index. | |
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| 650 | 0 | |a Biological products. |0 http://id.loc.gov/authorities/subjects/sh85014183 | |
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| 650 | 2 | 2 | |a Biological Products |
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| 776 | 0 | 8 | |i Print version: |a Whitmore, Elaine. |t Development of FDA-regulated medical products : a translational approach. |d Milwaukee, Wisconsin : ASQ Quality Press, 2012 |h xviii, 237 pages ; 24 cm |z 9780873898331 |w (DLC) 10929580 |
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Datensatz im Suchindex
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| author | Whitmore, Elaine |
| author_GND | http://id.loc.gov/authorities/names/n82272512 |
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| contents | Intro -- Table of Contents -- List of Figures and Tables -- Acronyms and Abbreviations -- Preface -- Part I Unique Challenges in Medical Product Development -- 1 Pushing the Pipeline -- 2 Healthcare in the United States -- 3 It's Not Your Father's FDA -- 4 Classifying Medical Products -- 5 Product Liability and Product Development -- Part II Bringing a New Medical Product to Market -- 6 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices -- 7 Quality by Design -- 8 Designing-Out Disaster: Risk Analysis -- 9 Recalls, Withdrawals, and Revocations -- 10 Human Factors and Usability Engineering -- 11 Is It Safe and Does It Work? -- 12 How Much Is the Product Really Worth? -- Part III Product Development Planning -- 13 Models and Metaphors -- 14 Components of Product Development Planning -- 15 Components of Product Development Planning -- 16 Components of Product Development Planning -- 17 Components of Product Development Planning -- 18 Better Double-Check That -- 19 Where Do We Go From Here? -- Appendix Resources -- Endnotes -- Glossary -- Index. |
| ctrlnum | (OCoLC)893681458 |
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| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-search | 615.1/9 |
| dewey-sort | 3615.1 19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| edition | Second edition. |
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| publisher | ASQ Quality Press, |
| record_format | marc |
| spelling | Whitmore, Elaine, author. https://id.oclc.org/worldcat/entity/E39PCjrmQMvhmF4hKrG3fcBCHC http://id.loc.gov/authorities/names/n82272512 Development of FDA-regulated medical products : a translational approach / Elaine Whitmore. Second edition. Milwaukee, Wisconsin : ASQ Quality Press, 2012. 1 online resource (255 pages) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier data file Includes bibliographical references and index. Print version record. English. Intro -- Table of Contents -- List of Figures and Tables -- Acronyms and Abbreviations -- Preface -- Part I Unique Challenges in Medical Product Development -- 1 Pushing the Pipeline -- 2 Healthcare in the United States -- 3 It's Not Your Father's FDA -- 4 Classifying Medical Products -- 5 Product Liability and Product Development -- Part II Bringing a New Medical Product to Market -- 6 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices -- 7 Quality by Design -- 8 Designing-Out Disaster: Risk Analysis -- 9 Recalls, Withdrawals, and Revocations -- 10 Human Factors and Usability Engineering -- 11 Is It Safe and Does It Work? -- 12 How Much Is the Product Really Worth? -- Part III Product Development Planning -- 13 Models and Metaphors -- 14 Components of Product Development Planning -- 15 Components of Product Development Planning -- 16 Components of Product Development Planning -- 17 Components of Product Development Planning -- 18 Better Double-Check That -- 19 Where Do We Go From Here? -- Appendix Resources -- Endnotes -- Glossary -- Index. United States. Food and Drug Administration. United States Food and Drug Administration United States. Food and Drug Administration fast Drug approval United States. Biological products Standards United States. Medical instruments and apparatus Standards United States. Biologicals. http://id.loc.gov/authorities/subjects/sh90002675 Biological products. http://id.loc.gov/authorities/subjects/sh85014183 Drug and Narcotic Control legislation & jurisprudence Biological Products Biological Factors Device Approval legislation & jurisprudence Drug Approval legislation & jurisprudence Government Regulation Translational Research, Biomedical United States Government Agencies United States Médicaments Autorisation de mise sur le marché États-Unis. Produits biologiques Normes États-Unis. Produits biologiques. Médicaments biologiques. MEDICAL Pharmacology. bisacsh Biological products Standards fast Drug approval fast Medical instruments and apparatus Standards fast United States fast https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq has work: Development of FDA-regulated medical products (Text) https://id.oclc.org/worldcat/entity/E39PCGMFfw3Q7MKPfBFkkKwqKm https://id.oclc.org/worldcat/ontology/hasWork Print version: Whitmore, Elaine. Development of FDA-regulated medical products : a translational approach. Milwaukee, Wisconsin : ASQ Quality Press, 2012 xviii, 237 pages ; 24 cm 9780873898331 (DLC) 10929580 FWS01 ZDB-4-EBA FWS_PDA_EBA https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=806710 Volltext |
| spellingShingle | Whitmore, Elaine Development of FDA-regulated medical products : a translational approach / Intro -- Table of Contents -- List of Figures and Tables -- Acronyms and Abbreviations -- Preface -- Part I Unique Challenges in Medical Product Development -- 1 Pushing the Pipeline -- 2 Healthcare in the United States -- 3 It's Not Your Father's FDA -- 4 Classifying Medical Products -- 5 Product Liability and Product Development -- Part II Bringing a New Medical Product to Market -- 6 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices -- 7 Quality by Design -- 8 Designing-Out Disaster: Risk Analysis -- 9 Recalls, Withdrawals, and Revocations -- 10 Human Factors and Usability Engineering -- 11 Is It Safe and Does It Work? -- 12 How Much Is the Product Really Worth? -- Part III Product Development Planning -- 13 Models and Metaphors -- 14 Components of Product Development Planning -- 15 Components of Product Development Planning -- 16 Components of Product Development Planning -- 17 Components of Product Development Planning -- 18 Better Double-Check That -- 19 Where Do We Go From Here? -- Appendix Resources -- Endnotes -- Glossary -- Index. United States. Food and Drug Administration. United States Food and Drug Administration United States. Food and Drug Administration fast Drug approval United States. Biological products Standards United States. Medical instruments and apparatus Standards United States. Biologicals. http://id.loc.gov/authorities/subjects/sh90002675 Biological products. http://id.loc.gov/authorities/subjects/sh85014183 Drug and Narcotic Control legislation & jurisprudence Biological Products Biological Factors Device Approval legislation & jurisprudence Drug Approval legislation & jurisprudence Government Regulation Translational Research, Biomedical United States Government Agencies Médicaments Autorisation de mise sur le marché États-Unis. Produits biologiques Normes États-Unis. Produits biologiques. Médicaments biologiques. MEDICAL Pharmacology. bisacsh Biological products Standards fast Drug approval fast Medical instruments and apparatus Standards fast |
| subject_GND | http://id.loc.gov/authorities/subjects/sh90002675 http://id.loc.gov/authorities/subjects/sh85014183 |
| title | Development of FDA-regulated medical products : a translational approach / |
| title_auth | Development of FDA-regulated medical products : a translational approach / |
| title_exact_search | Development of FDA-regulated medical products : a translational approach / |
| title_full | Development of FDA-regulated medical products : a translational approach / Elaine Whitmore. |
| title_fullStr | Development of FDA-regulated medical products : a translational approach / Elaine Whitmore. |
| title_full_unstemmed | Development of FDA-regulated medical products : a translational approach / Elaine Whitmore. |
| title_short | Development of FDA-regulated medical products : |
| title_sort | development of fda regulated medical products a translational approach |
| title_sub | a translational approach / |
| topic | United States. Food and Drug Administration. United States Food and Drug Administration United States. Food and Drug Administration fast Drug approval United States. Biological products Standards United States. Medical instruments and apparatus Standards United States. Biologicals. http://id.loc.gov/authorities/subjects/sh90002675 Biological products. http://id.loc.gov/authorities/subjects/sh85014183 Drug and Narcotic Control legislation & jurisprudence Biological Products Biological Factors Device Approval legislation & jurisprudence Drug Approval legislation & jurisprudence Government Regulation Translational Research, Biomedical United States Government Agencies Médicaments Autorisation de mise sur le marché États-Unis. Produits biologiques Normes États-Unis. Produits biologiques. Médicaments biologiques. MEDICAL Pharmacology. bisacsh Biological products Standards fast Drug approval fast Medical instruments and apparatus Standards fast |
| topic_facet | United States. Food and Drug Administration. United States Food and Drug Administration United States. Food and Drug Administration Drug approval United States. Biological products Standards United States. Medical instruments and apparatus Standards United States. Biologicals. Biological products. Drug and Narcotic Control legislation & jurisprudence Biological Products Biological Factors Device Approval legislation & jurisprudence Drug Approval legislation & jurisprudence Government Regulation Translational Research, Biomedical United States Government Agencies United States Médicaments Autorisation de mise sur le marché États-Unis. Produits biologiques Normes États-Unis. Produits biologiques. Médicaments biologiques. MEDICAL Pharmacology. Biological products Standards Drug approval Medical instruments and apparatus Standards |
| url | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=806710 |
| work_keys_str_mv | AT whitmoreelaine developmentoffdaregulatedmedicalproductsatranslationalapproach |