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The disarray in the regulatory approval process for introducing new medicines to patients around the world

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TitleInfo
Title
The disarray in the regulatory approval process for introducing new medicines to patients around the world
Name (type = personal)
NamePart (type = family)
Mazahreh
NamePart (type = given)
Saman
NamePart (type = date)
1979-
DisplayForm
Saman Mazahreh
Role
RoleTerm (authority = RULIB)
author
Name (type = personal)
NamePart (type = family)
Seiglie
NamePart (type = given)
Carlos
DisplayForm
Carlos Seiglie
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
chair
Name (type = personal)
NamePart (type = family)
Coate
NamePart (type = given)
Douglas
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Douglas Coate
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Spatareanu
NamePart (type = given)
Mariana
DisplayForm
Mariana Spatareanu
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
internal member
Name (type = personal)
NamePart (type = family)
Sultzbaugh
NamePart (type = given)
Susan
DisplayForm
Susan Sultzbaugh
Affiliation
Advisory Committee
Role
RoleTerm (authority = RULIB)
outside member
Name (type = corporate)
NamePart
Rutgers University
Role
RoleTerm (authority = RULIB)
degree grantor
Name (type = corporate)
NamePart
Graduate School - Newark
Role
RoleTerm (authority = RULIB)
school
TypeOfResource
Text
Genre (authority = marcgt)
theses
OriginInfo
DateCreated (qualifier = exact)
2014
DateOther (qualifier = exact); (type = degree)
2014-05
Place
PlaceTerm (type = code)
xx
Language
LanguageTerm (authority = ISO639-2b); (type = code)
eng
Abstract (type = abstract)
The pharmaceutical regulatory framework is a complex system requiring great diligence when requesting approval for a new medicine in different countries around the world. The hypothesis was that cost of an application for a new drug approval would play a major role in the country’s ability to review and approve a new drug. A study of the history of regulation, current gaps in the system, and regional harmonization efforts was conducted. Research and data collection on 129 countries was completed. Data included economic, development, political, and health indicators. Statistical analysis was conducted and some results confirmed part of the hypothesis while other results indicated that further study is needed. Stability of a government was confirmed to be a key factor in the drug approval process. The more stable the government, the more educated the population, the higher life expectancy because of increased access to medicine. As part of the research that led to the results above, it’s important to understand which governance structure is in place or needs to be installed? What are the next steps moving forward in gathering additional data from other companies, governments, and conducting a bigger research project that can confirm the results of this study? The World Health Organization, World Bank, International Monetary Fund, and other technical cooperative groups serve as forums that are collaborating to achieve better faster results. The term global affairs suggests that there are multiple subjects being discussed. The results of this paper imply and confirm that a multidisciplinary approach must be taken in order to enhance the current global pharmaceutical regulatory process.
Subject (authority = RUETD)
Topic
Global Affairs
RelatedItem (type = host)
TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier (type = RULIB)
ETD
Identifier
ETD_5611
PhysicalDescription
Form (authority = gmd)
electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
xv, 148 p. : ill.
Note (type = degree)
Ph.D.
Note (type = bibliography)
Includes bibliographical references
Note (type = vita)
Includes vita
Note (type = statement of responsibility)
by Saman Mazahreh
Subject (authority = ETD-LCSH)
Topic
Drug approval
Subject (authority = ETD-LCSH)
Topic
Drugs--Law and legislation
RelatedItem (type = host)
TitleInfo
Title
Graduate School - Newark Electronic Theses and Dissertations
Identifier (type = local)
rucore10002600001
Location
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NjNbRU
Identifier (type = doi)
doi:10.7282/T30V8B2S
Genre (authority = ExL-Esploro)
ETD doctoral
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Rights

RightsDeclaration (ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder (type = personal)
Name
FamilyName
Mazahreh
GivenName
Saman
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime (encoding = w3cdtf); (qualifier = exact); (point = start)
2014-04-30 13:54:50
AssociatedEntity
Name
Saman Mazahreh
Role
Copyright holder
Affiliation
Rutgers University. Graduate School - Newark
AssociatedObject
Type
License
Name
Author Agreement License
Detail
I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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Technical

RULTechMD (ID = TECHNICAL1)
ContentModel
ETD
OperatingSystem (VERSION = 5.1)
windows xp
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