Scale-Up Studies on High Shear Wet Granulation Process from Mini-Scale to Commercial Scale-Reference-Cited by-同舟云学术

Scale-Up Studies on High Shear Wet Granulation Process from Mini-Scale to Commercial Scale

Published:2008 Issue:10 Volume:56 Page:1431-1435
ISSN:0009-2363
Container-title:Chemical and Pharmaceutical Bulletin
language:en
Short-container-title:CHEMICAL & PHARMACEUTICAL BULLETIN

Author:

Aikawa Shouhei¹,Fujita Naomi¹,Myojo Hidetoshi¹,Hayashi Takashi¹,Tanino Tadatsugu²

Affiliation:

1. Oral Solid Formulation, CMC Development Laboratories, Shionogi & Co., Ltd.

2. Industrial Technology Laboratories, Shionogi & Co., Ltd.

Publisher

Pharmaceutical Society of Japan

Subject

Drug Discovery,General Chemistry,General Medicine

Link

https://www.jstage.jst.go.jp/article/cpb/56/10/56_10_1431/_pdf

Reference9 articles.

1. 1) ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8, Current Step 4 version (10 Nov. 2005).

2. 2) Joneckis C., “Changing the Paradigm of Process Validation,” presented in the 10th CMC strategy forum, NIH Campus, Bethesda, MD, U.S.A. on 20 July 2006.

3. 3) Achanta A. S., Adusumilli P., James K. W., Drug Dev. Ind. Pharm., 23, 539—546 (1997).

4. 4) Dieter A., Keleb E., Vervaet C., Remon J. P., Adams E., Massart D. L., Eur. J. Pharm. Sci., 17, 247—251 (2002).

5. 5) Ameye D., Keleb E., Vervaet C., Remon J. P., Adams E., Massart D. L., Eur. J. Pharm. Sci., 17, 247—251 (2002).

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