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

FindBook

Google Book

Amazon

博客來

Evaluating Recent Policies to Accelerate Generic Drug Entry.

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Evaluating Recent Policies to Accelerate Generic Drug Entry./
作者:	Chen, Shuxian.
面頁冊數:	1 online resource (140 pages)
附註:	Source: Dissertations Abstracts International, Volume: 82-08, Section: B.
Contained By:	Dissertations Abstracts International82-08B.
標題:	Pharmaceutical sciences. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=28264093click for full text (PQDT)
ISBN:	9798569995363

Evaluating Recent Policies to Accelerate Generic Drug Entry.
Chen, Shuxian.

Evaluating Recent Policies to Accelerate Generic Drug Entry. - 1 online resource (140 pages)

Source: Dissertations Abstracts International, Volume: 82-08, Section: B.

Thesis (Ph.D.)--University of Washington, 2020.

Includes bibliographical references

Generic drugs can bring more competition to the market and help to reduce drug costs. Governmental pharmaceutical regulations operate to balance innovation, access, and cost. Encouraging more generic entries is one mechanism to provide more competition. In this dissertation, we examined several recent policies that aim at accelerating generic drug entry. In Chapter 1, we presented a brief introduction about the background and rationale for the research. In Chapter 2, we evaluated whether the enactment of the Generic Drug User Fee Amendments (GDUFA) has already led to an increase in the speed of entry for different orders of entrants. In Chapter 3, we utilized both existing literature and nationally representative survey data to deepen our understanding of the changes in drug price and volume associated with more generic competition. In Chapter 4, we seek to estimate the potential economic impact from future policy to encourage faster generic entry, combining evidence of market dynamic changes from Chapter 3 as well as hazard of entry modeled in Chapter 2. Through the policy analysis in Chapter 2, we found that in markets where the first generic entered with patent challenge, GDFUA slowed the time-to-entry for the second entrant, but its impact was not significant for subsequent entries. GDUFA had null impact on the time-to-entry for the first generics that entered without patent challenge but significantly slowed down time to some of the subsequent generic entries. Our results suggest that GDUFA may have decelerated generic entries in the market beyond the first entry. Therefore, the overall price impact of this policy remains unclear. Future evaluation should combine the joint effect of GDUFA with future policies that specifically aim to accelerate subsequent generic entries. In Chapter 3, through meta-analysis, we found that more generic drug competition is associated with decreasing generic drug price, but not branded drug price, a finding known as the generic competition paradox. The Bayesian linear regression analysis found price reduction post-generic entry exists for both generic and branded drugs. It also revealed that generic market share and overall drug volume increase with respect to more generic competition. Lastly, in Chapter 4, we quantified the potential benefit from accelerating the approval of the first three generic entrants. Increased competition has minimum impact on drug expenditure reduction. This indicates that a general policy to expediate the review for the first three generics may not be as useful for expenditure reduction, as the total number of generic entrants is not affected.

Electronic reproduction.
Ann Arbor, Mich. :
ProQuest,
2023

Mode of access: World Wide Web

ISBN: 9798569995363Subjects--Topical Terms:

3173021
Pharmaceutical sciences.
Subjects--Index Terms:

Drug competitionIndex Terms--Genre/Form:

542853
Electronic books.

Evaluating Recent Policies to Accelerate Generic Drug Entry.
LDR:04010nmm a2200397K 4500 001 2357870
005 20230725053759.5
006 m o d
007 cr mn ---uuuuu
008 241011s2020 xx obm 000 0 eng d
020 $a 9798569995363
035 $a (MiAaPQ)AAI28264093
035 $a AAI28264093
040 $a MiAaPQ $b eng $c MiAaPQ $d NTU
100 1 $a Chen, Shuxian. $3 3698398
245 1 0 $a Evaluating Recent Policies to Accelerate Generic Drug Entry.
264 0 $c 2020
300 $a 1 online resource (140 pages)
336 $a text $b txt $2 rdacontent
337 $a computer $b c $2 rdamedia
338 $a online resource $b cr $2 rdacarrier
500 $a Source: Dissertations Abstracts International, Volume: 82-08, Section: B.
500 $a Advisor: Basu, Anirban.
502 $a Thesis (Ph.D.)--University of Washington, 2020.
504 $a Includes bibliographical references
520 $a Generic drugs can bring more competition to the market and help to reduce drug costs. Governmental pharmaceutical regulations operate to balance innovation, access, and cost. Encouraging more generic entries is one mechanism to provide more competition. In this dissertation, we examined several recent policies that aim at accelerating generic drug entry. In Chapter 1, we presented a brief introduction about the background and rationale for the research. In Chapter 2, we evaluated whether the enactment of the Generic Drug User Fee Amendments (GDUFA) has already led to an increase in the speed of entry for different orders of entrants. In Chapter 3, we utilized both existing literature and nationally representative survey data to deepen our understanding of the changes in drug price and volume associated with more generic competition. In Chapter 4, we seek to estimate the potential economic impact from future policy to encourage faster generic entry, combining evidence of market dynamic changes from Chapter 3 as well as hazard of entry modeled in Chapter 2. Through the policy analysis in Chapter 2, we found that in markets where the first generic entered with patent challenge, GDFUA slowed the time-to-entry for the second entrant, but its impact was not significant for subsequent entries. GDUFA had null impact on the time-to-entry for the first generics that entered without patent challenge but significantly slowed down time to some of the subsequent generic entries. Our results suggest that GDUFA may have decelerated generic entries in the market beyond the first entry. Therefore, the overall price impact of this policy remains unclear. Future evaluation should combine the joint effect of GDUFA with future policies that specifically aim to accelerate subsequent generic entries. In Chapter 3, through meta-analysis, we found that more generic drug competition is associated with decreasing generic drug price, but not branded drug price, a finding known as the generic competition paradox. The Bayesian linear regression analysis found price reduction post-generic entry exists for both generic and branded drugs. It also revealed that generic market share and overall drug volume increase with respect to more generic competition. Lastly, in Chapter 4, we quantified the potential benefit from accelerating the approval of the first three generic entrants. Increased competition has minimum impact on drug expenditure reduction. This indicates that a general policy to expediate the review for the first three generics may not be as useful for expenditure reduction, as the total number of generic entrants is not affected.
533 $a Electronic reproduction. $b Ann Arbor, Mich. : $c ProQuest, $d 2023
538 $a Mode of access: World Wide Web
650 4 $a Pharmaceutical sciences. $3 3173021
650 4 $a Public policy. $3 532803
653 $a Drug competition
653 $a Drug price
653 $a Generic drug
653 $a Health economics
653 $a Health policy
653 $a Policy analysis
655 7 $a Electronic books. $2 lcsh $3 542853
690 $a 0572
690 $a 0630
710 2 $a ProQuest Information and Learning Co. $3 783688
710 2 $a University of Washington. $b Pharmacy. $3 3186017
773 0 $t Dissertations Abstracts International $g 82-08B.
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=28264093 $z click for full text (PQDT)