Food and drug regulation in an era of globalized markets / (Record no. 85040)
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| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20230830103147.0 |
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| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||unuuu |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 150902t20152015ne ob 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780128025505 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 0128025506 |
| Qualifying information | (electronic bk.) |
| International Standard Book Number | 0128023112 |
| International Standard Book Number | 9780128023112 |
| Canceled/invalid ISBN | 9780128023112 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)919611878 |
| Canceled/invalid control number | (OCoLC)968043852 |
| -- | (OCoLC)969044783 |
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| -- | (OCoLC)1227629396 |
| -- | (OCoLC)1228601762 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | N$T |
| Language of cataloging | eng |
| Description conventions | rda |
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| Transcribing agency | N$T |
| Modifying agency | N$T |
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| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | K3636.F66 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | LAW |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 344.0423 |
| Edition number | 23 |
| 245 00 - TITLE STATEMENT | |
| Title | Food and drug regulation in an era of globalized markets / |
| Statement of responsibility, etc. | edited by Sam F. Halabi. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Amsterdam ; |
| -- | Boston : |
| Name of producer, publisher, distributor, manufacturer | Academic Press, an imprint of Elsevier, |
| Date of production, publication, distribution, manufacture, or copyright notice | [2015] |
| Date of production, publication, distribution, manufacture, or copyright notice | ©2015 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Front Cover; Food and Drug Regulation in an Era of Globalized Markets; Copyright; Contents; Contributors; Foreword; Introduction; The Rise of a Global System for Food and Pharmaceuticals; Conceptualizing Food and Drug Regulation in Globalized Markets: Interdisciplinarity and Governance; The Plan of This Book; Acknowledgments; Acknowledgments; Part I: Governance, Regulation, and Vulnerabilities of Globalized Pharmaceutical Supply Chains ; Chapter 1: Addressing Emerging Challenges in the Pharmaceutical Product Development Ecosystem; Introduction. |
| Formatted contents note | Approaches to Reduce Drug Development Costs and Speed InnovationClinical Trials: Reducing Costs, Speeding Development: New Approaches to Patient Recruitment, Study Design, and Settings; Adaptive Design; Clinical Trials: Globalization; New Approaches to Endpoints: Biomarkers, Patient Reporting, and Remote Monitoring; The Supply Chain: How Are We Vulnerable and What Are Potential Solutions?; Big (More and More) Data: Swim or Drown?; Conclusion; Chapter 2: FDA's Global Investigation and Enforcement Authority, Partnerships, and Priorities; Introduction; Adulteration, Misbranding, and GMPs. |
| Formatted contents note | FDA Establishment InspectionsFDA Enforcement Instruments Related to Manufacturing; Foreign Inspections; Conclusion; Chapter 3: The European Medicines Agency and the Regulation of Medicines in the European Union; Introduction; Approval of Drugs in Europe; The European Medicines Agency: Its Role and Activities; Ema Support In The Early Stages Of Drug Development; The Centralized Procedure AT WORK; Assessment overview; Single Assessment Report; Patients in the Scientific Review Process; Transparency and the Centralized Procedure; EMA-FDA Cooperation; Cooperation in the Product Life Cycle. |
| Formatted contents note | Cooperation in InspectionsBenefits of International Cooperation; References; Chapter 4: Human Clinical Trials and Drug Approvals: Transnational Issues; Introduction; Taking Clinical Trials Abroad; Overlapping Legal and Regulatory Requirements; Legal Landscape in the United States: FDA Oversight of Clinical Trials; Legal Landscape in the EU: EU Clinical Trial Directives and Regulation; International Legal Landscape: International Clinical Practice Standards; National and Local Legal Standards; Practical Considerations in Conducting Global Trials. |
| Formatted contents note | Deciding Whether to Conduct the Foreign Clinical Trial Under an INDIdentifying Experienced Contractors and Contract Research Organizations; Managing Idiosyncratic Foreign Sites and Investigators; Conclusion; Further Reading; Chapter 5: Falsified and Substandard Medicines in Globalized Pharmaceutical Supply Chains: Toward Actionable Solutions; Globalization's Influence on the Pharmaceutical Supply Chain; The Effects of the Global Market for Falsified and Substandard Medicines; Barriers to Global Solutions for the Problem of Falsified and Substandard Medicines. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. |
| 588 0# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Vendor-supplied metadata. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Law and legislation. |
| 9 (RLIN) | 63786 |
| Topical term or geographic name as entry element | Pharmacy |
| General subdivision | Law and legislation. |
| 9 (RLIN) | 63787 |
| Topical term or geographic name as entry element | Food law and legislation. |
| 9 (RLIN) | 63788 |
| Topical term or geographic name as entry element | LAW |
| General subdivision | Administrative Law & Regulatory Practice. |
| Source of heading or term | bisacsh |
| 9 (RLIN) | 63789 |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Law and legislation. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00898830 |
| 9 (RLIN) | 63790 |
| Topical term or geographic name as entry element | Food law and legislation. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00930954 |
| 9 (RLIN) | 63791 |
| Topical term or geographic name as entry element | Pharmacy |
| General subdivision | Law and legislation. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst01060303 |
| 9 (RLIN) | 63792 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Halabi, Sam F., |
| Relator term | editor. |
| 9 (RLIN) | 63793 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Title | Food and drug regulation in an era of globalized markets. |
| Place, publisher, and date of publication | London, England : Academic Press, ©2015 |
| Physical description | xli, 215 pages |
| International Standard Book Number | 9780128023112 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | ELSEVIER |
| Uniform Resource Identifier | <a href="https://www.sciencedirect.com/science/book/9780128023112">https://www.sciencedirect.com/science/book/9780128023112</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | eBooks |
No items available.