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dc.contributor.authorWolfgang, Edward Williamen_US
dc.date.accessioned2016-07-01T08:01:54Z
dc.date.available2016-07-01T08:01:54Z
dc.date.issued2016-06-30en_US
dc.identifier.othervt_gsexam:7610en_US
dc.identifier.urihttp://hdl.handle.net/10919/71690
dc.description.abstractUsing a Systems Theory approach allows a person to analyze the intertwined elements of the drug development system and the potential influences of the environment. Thomas Hughes's Large Technological Systems (LTS) Theory is one that could be used for this purpose; however, it falls short in its ability to address the complexity of current day regulatory environments. This dissertation provides a critical analysis of Hughes's LTS Theory and his phases of evolution as they apply to the United States (U.S.) system for biologic drug research, development and labeling. It identifies and explains potential flaws with Hughes's LTS Theory and provides suggested improvements. As an alternative approach, this dissertation explores the concept of "techno-regulatory system" where government regulators play an integral part in system innovations and explains why such systems do not always follow Hughes's model. Finally, this dissertation proposes a hybrid version of Hughes's systems approach and uses it to explain the changes that occurred in the drug approval system in response to the push for, opposition, and inclusion of, pediatric research in drug development during the period 1950-2003.en_US
dc.format.mediumETDen_US
dc.publisherVirginia Techen_US
dc.rightsThis Item is protected by copyright and/or related rights. Some uses of this Item may be deemed fair and permitted by law even without permission from the rights holder(s), or the rights holder(s) may have licensed the work for use under certain conditions. For other uses you need to obtain permission from the rights holder(s).en_US
dc.subjectLarge Technological Systems Theoryen_US
dc.subjectOrganizational Theoryen_US
dc.subjectCollaborative Theoryen_US
dc.subjectActor Network Theoryen_US
dc.subjectBiologicsen_US
dc.subjectPediatricsen_US
dc.subjectMedicineen_US
dc.subjectDrugsen_US
dc.titleA Systems Approach to Understanding the History of U.S. Pediatric Biologic Drug Research and Labelingen_US
dc.typeDissertationen_US
dc.contributor.departmentScience and Technology in Societyen_US
dc.description.degreePh. D.en_US
thesis.degree.namePh. D.en_US
thesis.degree.leveldoctoralen_US
thesis.degree.grantorVirginia Polytechnic Institute and State Universityen_US
thesis.degree.disciplineScience and Technology Studiesen_US
dc.contributor.committeechairBrown, Shannon A.en_US
dc.contributor.committeechairAbbate, Janet E.en_US
dc.contributor.committeememberLaberge, Ann F.en_US
dc.contributor.committeememberZwanziger, Lee L.en_US
dc.contributor.committeememberWally, Jeremyen_US


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