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A pharmaceutical risk management model.

Bui, Thu-Tam T.

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A pharmaceutical risk management model.

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	A pharmaceutical risk management model./
作者:	Bui, Thu-Tam T.
面頁冊數:	144 p.
附註:	Source: Dissertation Abstracts International, Volume: 69-01, Section: B, page: 0252.
Contained By:	Dissertation Abstracts International69-01B.
標題:	Health Sciences, Pharmacy. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3300391
ISBN:	9780549449867

A pharmaceutical risk management model.
Bui, Thu-Tam T.

A pharmaceutical risk management model. - 144 p.

Source: Dissertation Abstracts International, Volume: 69-01, Section: B, page: 0252.

Thesis (Ph.D.)--The University of Oklahoma Health Sciences Center, 2006.

The history of pharmaceutical risk management by the Food and Drug Administration (FDA) and drug manufacturers has been one of responding post hoc to serious and frequent adverse events. In addition, the risk management programs implemented have had varying effectiveness in protecting public safety and ensuring the viability of drugs. One reason for this is the lack of a systematic approach for evaluating risk and implementing risk management programs. The objectives of this study were to: (1) identify characteristics of drug products that affect the management of risks, (2) define variables that affect the outcome of a drug product withdrawal, (3) develop a model that quantifies the amount of risks inherent in a drug product, and (4) demonstrate the utility of a risk management model to predict the outcome of drug withdrawal. The goal is to move towards an active role in risk management rather than a role that is passive and reactive.

ISBN: 9780549449867Subjects--Topical Terms:

1017737
Health Sciences, Pharmacy.

A pharmaceutical risk management model.
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500 $a Source: Dissertation Abstracts International, Volume: 69-01, Section: B, page: 0252.
500 $a Adviser: Kevin Farmer.
502 $a Thesis (Ph.D.)--The University of Oklahoma Health Sciences Center, 2006.
520 $a The history of pharmaceutical risk management by the Food and Drug Administration (FDA) and drug manufacturers has been one of responding post hoc to serious and frequent adverse events. In addition, the risk management programs implemented have had varying effectiveness in protecting public safety and ensuring the viability of drugs. One reason for this is the lack of a systematic approach for evaluating risk and implementing risk management programs. The objectives of this study were to: (1) identify characteristics of drug products that affect the management of risks, (2) define variables that affect the outcome of a drug product withdrawal, (3) develop a model that quantifies the amount of risks inherent in a drug product, and (4) demonstrate the utility of a risk management model to predict the outcome of drug withdrawal. The goal is to move towards an active role in risk management rather than a role that is passive and reactive.
520 $a This study had two phases. The first phase was the development of a predictive model for the outcome of drug withdrawal. It incorporated the underlying factors influencing the need for risk management such as incidence of occurrence of an adverse event, severity of an adverse event, and deaths reported. This process involved analyzing drug profiles to identify characteristics that were subsequently defined as the independent variables, and then modeling their effects on the dependent variable of drug withdrawal to quantifying risks. The second phase of the study was model validation. Model results were used to predict the risk of drug product withdrawal.
590 $a School code: 0361.
650 4 $a Health Sciences, Pharmacy. $3 1017737
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710 2 $a The University of Oklahoma Health Sciences Center. $3 1023966
773 0 $t Dissertation Abstracts International $g 69-01B.
790 1 0 $a Farmer, Kevin, $e advisor
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792 $a 2006
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