切換：
- 簡略
- 詳細(MARC)
- ISBD
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Design and Analysis of Bridging Studies
紀錄類型 ： 書目-語言資料,印刷品: 單行本
其他作者 ： Liu, Jen-pei
出版者 ： Boca Raton Taylor & Francis2013.
面頁冊數 ： xviii, 269 p.ill. ;24 cm.
簡介 ： "In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for the product development. To address this issue, a general framework has been provided by the ICH E5 (1998) in a document titled "Ethnic Factors in the Acceptability of Foreign Clinical Data" for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the test medical product to the needed patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them"--Provided by publisher.
標題 ： Clinical Trials as Topic - standards. -
標題 ： Drug Evaluation, Preclinical - standards. -
標題 ： Biostatistics - methods. -
標題 ： Internationality. -
標題 ： Research Design. -
ISBN ： 9781439846346 (hardcover : alk. paper)
ISBN ： 1439846340 (hardcover : alk. paper)
LEADER 02559cam a22002658a 4500
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008 130516s2013 flua b 001 0 eng
010 $a2012015476
020 $a9781439846346 (hardcover : alk. paper)
020 $a1439846340 (hardcover : alk. paper)
035 $a(OCoLC)794257385$z(OCoLC)587104313
035 $a.b20589359
040 $aDNLM/DLC$beng$cDLC$dBTCTA$dYDXCP$dNLM
041 0#$aeng
042 $anbic
050 #4$aRM301.27$b.D475 2012
082 00$a615.10724$223
245 00$aDesign and Analysis of Bridging Studies $ceditors, Jen-Pei Liu, Shein-Chung Chow, Chin-Fu Hsiao
260 # $aBoca Raton $bTaylor & Francis$c2013.
263 $a1207.
300 $axviii, 269 p.$bill. ;$c24 cm.
490 1 $aChapman & Hall/CRC Biostatistics Series.
504 $aIncludes Bibliographical References and Index.
520 # $a"In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for the product development. To address this issue, a general framework has been provided by the ICH E5 (1998) in a document titled "Ethnic Factors in the Acceptability of Foreign Clinical Data" for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the test medical product to the needed patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them"--Provided by publisher.
650 12$aClinical Trials as Topic$xstandards.$350225
650 12$aDrug Evaluation, Preclinical$xstandards.$350226
650 22$aBiostatistics$xmethods.$350227
650 22$aGuidelines as Topic.$350228
650 22$aInternationality.$350229
650 22$aResearch Design.$324192
700 1#$aLiu, Jen-pei $d1952- $350238
700 1#$aChow, Shein-Chung, $d1955- $350239
700 1#$aHsiao, Chin-Fu$d1964-$350240
830 0$aChapman & Hall/CRC biostatistics series (Unnumbered)$350237
Design and Analysis of Bridging Studies editors, Jen-Pei Liu, Shein-Chung Chow, Chin-Fu Hsiao - Boca Raton Taylor & Francis2013. - xviii, 269 p.ill. ;24 cm. - Chapman & Hall/CRC Biostatistics Series.. - Chapman & Hall/CRC biostatistics series (Unnumbered).
Includes Bibliographical References and Index.
"In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for the product development. To address this issue, a general framework has been provided by the ICH E5 (1998) in a document titled "Ethnic Factors in the Acceptability of Foreign Clinical Data" for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the test medical product to the needed patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them"--Provided by publisher.
ISBN: 9781439846346 (hardcover : alk. paper)
LCCN: 2012015476Subjects--Topical Terms:
50225
Clinical Trials as Topic
--standards.
LC Class. No.: RM301.27 / .D475 2012
Dewey Class. No.: 615.10724
Includes Bibliographical References and Index.
"In recent years, the variations of pharmaceutical products in efficacy and safety among different geographic regions due to ethic factors is a matter of great concern for sponsors as well as for regulatory authorities. However, the key issues lie on when and how to address the geographic variations of efficacy and safety for the product development. To address this issue, a general framework has been provided by the ICH E5 (1998) in a document titled "Ethnic Factors in the Acceptability of Foreign Clinical Data" for evaluation of the impact of ethnic factors on the efficacy, safety, dosage, and dose regimen. The ICH E5 guideline provides regulatory strategies for minimizing duplication of clinical data and requirements for bridging evidence to extrapolate foreign clinical data to a new region. More specifically, the ICH E5 guideline suggests that a bridging study should be conducted in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen to allow extrapolation of the foreign clinical data to the population of the new region. However, a bridging study may require significant development resources and also delay availability of the test medical product to the needed patients in the new region. To accelerate the development process and shorten approval time, the design of multiregional trials incorporates subjects from many countries around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them"--Provided by publisher.
ISBN: 9781439846346 (hardcover : alk. paper)
LCCN: 2012015476Subjects--Topical Terms:
50225
Clinical Trials as Topic
--standards.
LC Class. No.: RM301.27 / .D475 2012
Dewey Class. No.: 615.10724
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