Survey Results for In Vitro-In Vivo Correlations (IVIVC): Critical Variables for Success

被引：9

作者：

Fotaki, Nikoletta ^{[1
]}

Gray, Vivian ^{[2
]}

Kesisoglou, Filippos ^{[3
]}

Mayock, Steve ^{[4
]}

Mirza, Tahseen ^{[5
]}

Salt, Alger ^{[6
]}

Selen, Arzu ^{[7
]}

机构：

[1] Univ Bath, Dept Pharm & Pharmacol, Bath BA2 7AY, Avon, England

[2] Dissolut Technol, Hockessin, DE 19707 USA

[3] Merck Sharp & Dohme Corp, Biopharmaceut Product Value Enhancement Pharmaceu, West Point, PA USA

[4] Collegium Pharmaceut Inc, Canton, MA USA

[5] US FDA, Off Mfg & Product Qual, Off Compliance, CDER, Silver Spring, MD USA

[6] GlaxoSmithKline, Product Dev Lab Automat & Platforms, Res Triangle Pk, NC USA

[7] US FDA, Off New Drug Qual Assessment, CDER, Silver Spring, MD USA

来源：

DISSOLUTION TECHNOLOGIES | 2013年 / 20卷 / 02期

关键词：

D O I：

10.14227/DT200213P48

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

This report summarizes the results of the "In Vitro-In Vivo Correlations (IVIVC): Critical Variables for Success" survey organized by the In Vitro Release and Dissolution Testing (IVRDT) and the QbD and Product Performance AAPS Focus Groups. This was a web-based survey conducted over a 26-day period from Wednesday, June 29, 2011, to Sunday, July 24, 2011, and results were initially presented at the 2011 AAPS Annual Meeting and Exposition. The goal was to describe the current views from scientists across academia, industry, and regulatory agencies on the adoption, utility, and benefits of IVIVCs and to begin identifying potentially critical variables for their success. Questions in the survey cover their development, use, and success.

引用

页码：48 / 50

页数：3