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A dose finding method in joint modeling of efficacy and safety endpoints in phase II studies
Descriptive
TypeOfResource
Text
TitleInfo
(ID = T-1)
Title
A dose finding method in joint modeling of efficacy and safety endpoints in phase II studies
SubTitle
an extension of the MCP-mod method
Identifier
ETD_2466
Identifier
(type = hdl)
http://hdl.rutgers.edu/1782.2/rucore10001600001.ETD.000053217
Language
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eng
Genre
(authority = marcgt)
theses
Subject
(ID = SBJ-1);
(authority = RUETD)
Topic
Public Health
Subject
(ID = SBJ-2);
(authority = ETD-LCSH)
Topic
Dose-response relationship (Biochemistry)
Subject
(ID = SBJ-3);
(authority = ETD-LCSH)
Topic
Drugs--Dosage
Subject
(ID = SBJ-4);
(authority = ETD-LCSH)
Topic
Drugs--Effectiveness
Abstract
(type = abstract)
Determination of appropriate dose(s) to advance into Phase III is one of the most challenging and important decisions made during drug development. Selecting a dose too high may result in unacceptable safety problems, while a too low dose may lead to ineffective drugs. Proper estimation of such dose-response profiles for relevant safety and efficacy endpoints allows the reliable evaluation of the risk-benefit profile of a drug at the end of Phase II, as well as the selection of appropriate doses to be brought into confirmatory Phase III trials. This dissertation will address how to select dose(s) in Phase II trials by combining information about the efficacy and safety in a joint model setting. The methods we present in the dissertation may play a key role in drug development programs, and are often the gate-keeper for large confirmatory Phase III trials with greater chance of successful approval. The dose selection when both safety and efficacy are represented by continuous responses is discussed in Part I of the dissertation, while Part II addresses the methodology when the safety and efficacy are mixed type responses. Both scenarios involve joint modeling of safety and efficacy endpoints. The methodology will focus on the following: (1) Joint modeling approaches; (2) Model selection; (3) Identification of minimum effective dose (MED) and maximum safety dose(MSD); (4) Selection of optimal dose(s) for the Phase III program.
PhysicalDescription
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electronic resource
Extent
xvi, 212 p. : ill.
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Note
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Ph.D.
Note
Includes abstract
Note
Vita
Note
(type = bibliography)
Includes bibliographical references
Note
(type = statement of responsibility)
by Aiyang Tao
Name
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Tao
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Aiyang
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1968-
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author
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Aiyang Tao
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LIN
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YONG
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chair
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Advisory Committee
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YONG LIN
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NamePart
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Shih
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(type = given)
Weichung Joe
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internal member
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Advisory Committee
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Weichung Joe Shih
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Ohman Strickland
NamePart
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Pamela A.
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Advisory Committee
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Pamela A. Ohman Strickland
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Pinheiro
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Jose
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outside member
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Advisory Committee
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Jose Pinheiro
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NamePart
Rutgers University
Role
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degree grantor
Name
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Graduate School - New Brunswick
Role
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school
OriginInfo
DateCreated
(qualifier = exact)
2010
DateOther
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(type = degree)
2010
Place
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xx
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TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier
(type = RULIB)
ETD
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(type = host)
TitleInfo
Title
Graduate School - New Brunswick Electronic Theses and Dissertations
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rucore19991600001
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NjNbRU
Identifier
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doi:10.7282/T3GT5N82
Genre
(authority = ExL-Esploro)
ETD doctoral
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Rights
RightsDeclaration
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The author owns the copyright to this work.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
RightsHolder
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(type = personal)
Name
FamilyName
Tao
GivenName
Aiyang
Role
Copyright Holder
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Type
Permission or license
DateTime
2010-02-18 12:11:52
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Name
Aiyang Tao
Affiliation
Rutgers University. Graduate School - New Brunswick
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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.
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Technical
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ETD
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application/pdf
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application/x-tar
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1310720
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