A Perspective for Biowaivers of Human Bioequivalence Studies on the Basis of the Combination of the Ratio of AUC to the Dose and the Biopharmaceutics Classification System-Reference-Cited by-同舟云学术

A Perspective for Biowaivers of Human Bioequivalence Studies on the Basis of the Combination of the Ratio of AUC to the Dose and the Biopharmaceutics Classification System

Published:2011-06-17 Issue:4 Volume:8 Page:1113-1119
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Sakuma Shinji¹,Tachiki Hidehisa²,Uchiyama Hitoshi²,Fukui Yasunobu³,Takeuchi Naohiro³,Kumamoto Kazuo⁴,Satoh Tomonori⁴,Yamamoto Yoshinobu⁵,Ishii Emi⁵,Sakai Yoshiyuki⁶,Takeuchi Susumu⁷,Sugita Masaru⁷,Yamashita Shinji¹

Affiliation:

1. Faculty of Pharmaceutical Sciences, Setsunan University, 45-1, Nagaokatoge-cho, Hirakata, Osaka 573-0101, Japan

2. Research & Development Division, Towa Pharmaceutical Co., Ltd., 32-8, Kuwazai-shinmachi, Kadoma, Osaka 571-0043, Japan

3. Research Center, Kyowa Pharmaceutical Industry Co., Ltd., 6-7-2, Yurinokidai, Sanda, Hyogo 669-1324, Japan

4. Pharmaceutical Development Center, Nichi-Iko Pharmaceutical Co., Ltd., 205-1 Shimo-umezawa, Namerikawa, Toyama 936-0857, Japan

5. Drug Development Laboratory, Ohara Pharmaceutical Co., Ltd., 121-15, Toriino, Koka-cho, Koka, Shiga 520-3403, Japan

6. Research & Development Division, Taiyo Pharmaceutical Industry Co., Ltd., 1-24-11, Taiko, Nakamura-ku, Nagoya, Aichi 453-0801, Japan

7. Biological Research Department, Sawai Pharmaceutical Co., Ltd., 2-30, Miyahara 5-chome, Yodogawa-ku, Osaka 532-0003, Japan

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/mp100421j

Reference23 articles.

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2. Analysis of Risk Factors in Human Bioequivalence Study That Incur Bioinequivalence of Oral Drug Products

3. Correlation between in vitro dissolution profiles from enteric-coated dosage forms and in vivo absorption in rats for high-solubility and high-permeability model drugs

4. Guideline for Bioequivalence Studies of Generic Products;National Institute of Health Sciences:Tokyo, Japan, 2006.http://www.nihs.go.jp/drug/be-guide(e)/be2006e.pdf(accessed March 2011) .

5. Guidance on the Investigation of Bioequivalence;European Medicines Agency:London, U.K., 2010.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf(accessed March 2011) .

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