Abuse of Minors in Clinical Studies : (Record no. 36115)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04898nam a22004333i 4500 |
| 001 - CONTROL NUMBER | |
| control field | EBC30545989 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | MiAaPQ |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240724115926.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d | |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 240724s2023 xx o ||||0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781804411360 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9781804411353 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (MiAaPQ)EBC30545989 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (Au-PeEL)EBL30545989 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1379756711 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | MiAaPQ |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | MiAaPQ |
| Modifying agency | MiAaPQ |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RJ560 .R674 2023 |
| 082 0# - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.1083 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Rose, Klaus. |
| 245 10 - TITLE STATEMENT | |
| Title | Abuse of Minors in Clinical Studies : |
| Remainder of title | A Worldwide Ethical Challenge for the 21st Century. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st ed. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Bradford : |
| Name of producer, publisher, distributor, manufacturer | Ethics International Press Limited, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2023. |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | ©2023. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (305 pages) |
| 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 |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Intro -- Foreword -- Chapter 1 -- Introduction -- References -- Chapter 2 -- Care of Children in History -- Midwifery, classical academic medicine, and medicine's ancient roots -- Hygiene and prevention of infectious diseases -- Baby & -- infant nutrition -- Child advocacy -- The American Academy of Pediatrics (AAP) and conflicts of interest -- Children's rights and their alleged right to have properly tested medicines -- Conclusions -- References -- Chapter 3 -- What is a Child? -- Conclusion -- References -- Chapter 4 -- Emergence of Pediatric Medicine in the 20th Century -- Surgery -- Cancer and other malignancies -- Vaccines and vaccination -- Rheumatology -- Depression -- Conclusion -- References -- Chapter 5 -- The Thalidomide Disaster Triggers Modern Drug Development -- References -- Chapter 6 -- Children as "Therapeutic Orphans" and Developmental Pharmacology -- No major disasters in pediatric medicine -- Developmental physiology and pharmacology -- Children: a neglected population? -- On-label/ off-label use of drugs in children -- Extrapolation from adults to "children" -- Pediatric exclusivity -- Reality is slowly kicking in, but this is not yet officially recognized -- References -- Chapter 7 -- Questionable Pediatric Studies -- Cancer and malignancies before the 18th birthday -- Malignant melanoma -- Autoimmune arthritis in minors/ juvenile idiopathic arthritis (JIA) -- Epilepsy -- Regulatory territorial demands -- Bizarre conclusions from pointless studies -- Misogynist studies -- Multiple sclerosis -- Further questionable studies -- Conclusions -- References -- Chapter 8 -- The Declaration of Helsinki and Research in Minors -- References -- Chapter 9 -- The International Committee of Medical Journal Editors (ICMJE) -- References -- Chapter 10 -- The Council for International Organizations of Medical Sciences (CIOMS). |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | References -- Chapter 11 -- Institutional Review Boards (IRBs) and Ethics Committees (ECs) -- References -- Chapter 12 -- Gillick Competence -- References -- Chapter 13 -- New Conflicts of Interest in Medical Research -- References -- Chapter 14 -- Neonatology -- References -- Chapter 15 -- Conclusions and Outlook -- References. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called "Pediatric Drug Development" (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies. |
| 588 ## - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Description based on publisher supplied metadata and other sources. |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pediatric pharmacology-Handbooks, manuals, etc. |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Main entry heading | Rose, Klaus |
| Title | Abuse of Minors in Clinical Studies |
| Place, publisher, and date of publication | Bradford : Ethics International Press Limited,c2023 |
| International Standard Book Number | 9781804411353 |
| 797 2# - LOCAL ADDED ENTRY--CORPORATE NAME (RLIN) | |
| Corporate name or jurisdiction name as entry element | ProQuest (Firm) |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://ebookcentral.proquest.com/lib/orpp/detail.action?docID=30545989">https://ebookcentral.proquest.com/lib/orpp/detail.action?docID=30545989</a> |
| Public note | Click to View |
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