東華大學圖書館 |

語系: 繁體中文

說明(常見問題)

回圖書館首頁

手機版館藏查詢

登入

回首頁

切換: 標籤 | MARC模式 | ISBD

Risk Assessment Using Paired Compari...

Okwesili, Paul C., Jr.

FindBook

Google Book

Amazon

博客來

Risk Assessment Using Paired Comparison Expert Elicitation for Ranking of Compounding Outsourcing Facilities.

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Risk Assessment Using Paired Comparison Expert Elicitation for Ranking of Compounding Outsourcing Facilities./
作者:	Okwesili, Paul C., Jr.
面頁冊數:	173 p.
附註:	Source: Dissertation Abstracts International, Volume: 77-08(E), Section: B.
Contained By:	Dissertation Abstracts International77-08B(E).
標題:	Systems science. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=10076304
ISBN:	9781339586052

Risk Assessment Using Paired Comparison Expert Elicitation for Ranking of Compounding Outsourcing Facilities.
Okwesili, Paul C., Jr.

Risk Assessment Using Paired Comparison Expert Elicitation for Ranking of Compounding Outsourcing Facilities. - 173 p.

Source: Dissertation Abstracts International, Volume: 77-08(E), Section: B.

Thesis (Ph.D.)--The George Washington University, 2016.

In 2012, improperly compounded sterile products caused an outbreak of fungal meningitis and other fungal infections to become the largest outbreak of healthcare-associated infections in the United States. This outbreak, along with other adverse events associated with larger compounders demonstrated a significant public health risk and highlighted the need for more-rigorous regulatory oversight of pharmacy compounding. In response, the U.S. Congress passed the Drug Quality and Security Act in November 2013, giving the Food and Drug Administration (FDA) authority to oversee compounding outsourcing facilities. However, even with the new authority, the regulators are faced with the challenge of safeguarding the public against improperly compounded products despite limited data and resources. This dissertation will discuss a novel application of the paired comparison expert elicitation technique to develop a risk-ranking model that can allow regulators to efficiently allocate their resources and focus on compounding firms that could pose the greatest risk. Empirical research on the factors that can assess compounding risks is explored to understand their influences. Sensitivity analysis of these risk factors identified the top factors that had the most significant effect on the outcome of the quantitative risk assessment model. The resulting model from this research is inclusive as it was developed with inputs from experts from the FDA, the States Board of Pharmacy, and members of the compounding industry. As such, it can be beneficial to stakeholders from both the private and public pharmacy compounding sectors. Prior to conducting the paired comparison expert elicitation, a gap analysis is performed to gain a better understanding of the pharmacy compounding regulations among the states and to identify the gaps in the state regulation and oversight of the compounding industry.

ISBN: 9781339586052Subjects--Topical Terms:

3168411
Systems science.

Risk Assessment Using Paired Comparison Expert Elicitation for Ranking of Compounding Outsourcing Facilities.
LDR:02904nmm a2200313 4500 001 2078538
005 20161129073703.5
008 170521s2016 ||||||||||||||||| ||eng d
020 $a 9781339586052
035 $a (MiAaPQ)AAI10076304
035 $a AAI10076304
040 $a MiAaPQ $c MiAaPQ
100 1 $a Okwesili, Paul C., Jr. $3 3194130
245 1 0 $a Risk Assessment Using Paired Comparison Expert Elicitation for Ranking of Compounding Outsourcing Facilities.
300 $a 173 p.
500 $a Source: Dissertation Abstracts International, Volume: 77-08(E), Section: B.
500 $a Advisers: Thomas Mazzuchi; Shahram Sarkani.
502 $a Thesis (Ph.D.)--The George Washington University, 2016.
520 $a In 2012, improperly compounded sterile products caused an outbreak of fungal meningitis and other fungal infections to become the largest outbreak of healthcare-associated infections in the United States. This outbreak, along with other adverse events associated with larger compounders demonstrated a significant public health risk and highlighted the need for more-rigorous regulatory oversight of pharmacy compounding. In response, the U.S. Congress passed the Drug Quality and Security Act in November 2013, giving the Food and Drug Administration (FDA) authority to oversee compounding outsourcing facilities. However, even with the new authority, the regulators are faced with the challenge of safeguarding the public against improperly compounded products despite limited data and resources. This dissertation will discuss a novel application of the paired comparison expert elicitation technique to develop a risk-ranking model that can allow regulators to efficiently allocate their resources and focus on compounding firms that could pose the greatest risk. Empirical research on the factors that can assess compounding risks is explored to understand their influences. Sensitivity analysis of these risk factors identified the top factors that had the most significant effect on the outcome of the quantitative risk assessment model. The resulting model from this research is inclusive as it was developed with inputs from experts from the FDA, the States Board of Pharmacy, and members of the compounding industry. As such, it can be beneficial to stakeholders from both the private and public pharmacy compounding sectors. Prior to conducting the paired comparison expert elicitation, a gap analysis is performed to gain a better understanding of the pharmacy compounding regulations among the states and to identify the gaps in the state regulation and oversight of the compounding industry.
590 $a School code: 0075.
650 4 $a Systems science. $3 3168411
650 4 $a Management. $3 516664
650 4 $a Organizational behavior. $3 516683
650 4 $a Public health. $3 534748
650 4 $a Pharmaceutical sciences. $3 3173021
690 $a 0790
690 $a 0454
690 $a 0703
690 $a 0573
690 $a 0572
710 2 $a The George Washington University. $b Engineering Mgt and Systems Engineering. $3 1028210
773 0 $t Dissertation Abstracts International $g 77-08B(E).
790 $a 0075
791 $a Ph.D.
792 $a 2016
793 $a English
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=10076304