PQRI Workshop Report: Application of IVIVC in Formulation Development

被引：6

作者：

Van Buskirk, Glenn A. ^{[1
]}

Shah, Vinod

Yacobi, Avi ^{[2
]}

Bolger, Michael B. ^{[3
]}

Chittenden, Jason ^{[4
]}

Davit, Barbara M. ^{[5
]}

DeStefano, Anthony ^{[6
]}

Dressman, Jennifer ^{[7
]}

Duan, John Z. ^{[5
]}

Ganes, Derek A. ^{[8
]}

Gonzalez, Mario A. ^{[9
]}

Gray, Vivian ^{[10
]}

Kakhi, Maziar ^{[5
]}

Li, Rong ^{[11
]}

Mirza, Tasheen ^{[5
]}

Polli, James E. ^{[12
]}

Rackley, Russell J. ^{[13
]}

Smith, Douglas F. ^{[14
]}

Shephard, Theresa ^{[15
]}

Stippler, Erika ^{[16
]}

Suarez-Sharp, Sandra ^{[5
]}

Turner, David ^{[17
]}

机构：

[1] Nonclin Drug Dev Consulting Serv LLC, Basking Ridge, NJ 07920 USA

[2] DOLE Pharma LLC, Englewood, NJ 07631 USA

[3] Simulat Plus Inc, Lancaster, CA 93534 USA

[4] Pharsight Certara Co, St Louis, MO 63101 USA

[5] Food & Drug Adm, Silver Spring, MD 20993 USA

[6] YourEncore, Gaithersburg, MD 20882 USA

[7] Goethe Univ Frankfurt, D-60438 Frankfurt, Germany

[8] Ganes Pharma Inc, Toronto, ON M2N 4B4, Canada

[9] PKinet Int Inc, Pembroke Pines, FL 33207 USA

[10] Dissolut Technol, Hockessin, DE 19707 USA

[11] Pfizer Inc, Groton, CT 06340 USA

[12] Univ Maryland, Baltimore, MD 21201 USA

[13] Mylan Pharmaceut, Morgantown, WV 26505 USA

[14] DFS Consulting LLC, Tucson, AZ 85718 USA

[15] Med & Healthcare Prod Regulatory Agcy MHRA, London SW 1W9SZ, England

[16] United States Pharmacopeia, Rockville, MD 20852 USA

[17] SimCYP, Sheffield S24 SU, S Yorkshire, England

来源：

DISSOLUTION TECHNOLOGIES | 2014年 / 21卷 / 02期

关键词：

D O I：

10.14227/DT210214P51

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

This article summarizes the proceeding of the September 2012 Workshop on Application of In vitro In vivo correlation (IVIVC) in Formulation Development. The workshop brought together international experts with the goal of establishing common concepts that could be utilized to facilitate the development and validation of IVIVCs in the registration of and post-approval changes to oral solid dosage forms. The workshop was organized by the Product Quality Research Institute (PORI) and cosponsored by AAPS, FDA, FIP, and USP. Open access of this information is available to all interested parties.

引用

页码：51 / 58

页数：8

共 7 条

[1]

*CHMP, 2013, EMACHMPEWP28096 EUR

[2]

*CHMP, 1999, EMACHMPQVVP60496 EUR

[3] NEW METHOD FOR CALCULATING INTRINSIC ABSORPTION RATE OF DRUGS [J].

LOO, JCK ;

RIEGELMA.S .

JOURNAL OF PHARMACEUTICAL SCIENCES, 1968, 57 (06) :918-&

[4] Developing In Vitro-In Vivo Correlation of Risperidone Immediate Release Tablet [J].

Saibi, Yardi ;

Sato, Hitoshi ;

Tachiki, Hidehisa .

AAPS PHARMSCITECH, 2012, 13 (03) :890-895

[5]

United States Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), 1997, EXT REL OR DOS FORMS

[6]

*US PHARM CONV INC, 2013, US PHARM NAT FOR S2

[7] PER CENT ABSORBED TIME PLOTS DERIVED FROM BLOOD LEVEL AND/OR URINARY EXCRETION DATA [J].

WAGNER, JG ;

NELSON, E .

JOURNAL OF PHARMACEUTICAL SCIENCES, 1963, 52 (06) :610-&

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