Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products-Reference-Cited by-同舟云学术

Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products

Published:2015-11-20 Issue:12 Volume:12 Page:4405-4413
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Sugihara Masahisa¹,Takeuchi Susumu¹,Sugita Masaru¹,Higaki Kazutaka²,Kataoka Makoto³,Yamashita Shinji³

Affiliation:

1. Sawai Pharmaceutical Co., Ltd., 5-2-30 Miyahara, Yodogawa-ku, Osaka, Osaka 532-0003, Japan

2. Faculty of Pharmaceutical Sciences, Okayama University, 1-1-1 Tsushima-naka, Kita-ku, Okayama 700-8530, Japan

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

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.5b00602

Reference28 articles.

1. Guidance for Industry, Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs—General Considerations;US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research: 2014.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM389370.pdf. Accessed 27 Jun 2015.

2. Guideline, the investigation of bioequivalence. Committee for Medicinal Products for Human Use (CHMP);European Medicines Agency (EMA): 2010.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf. Accessed 27 Jun 2015.

3. National Institute of Health Sciences Guideline, bioequivalence studies of generic products;Japanese Pharmaceutical and Food Safety Bureau, Minister of Health, Labor and Welfare: 2012.http://www.nihs.go.jp/drug/be-guide(e)/Generic/GL-E_120229_BE.pdf. Accessed 27 Jun 2015.

4. International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences

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

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