Bioequivalence Study of Erlotinib Tablets 25 mg/150 mg “NK” in Healthy Male Volunteers with an Adaptive Design-Reference-Cited by-同舟云学术

Bioequivalence Study of Erlotinib Tablets 25 mg/150 mg “NK” in Healthy Male Volunteers with an Adaptive Design

Published:2024-05-31 Issue:3 Volume:55 Page:117-124
ISSN:0388-1601
Container-title:Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
language:en
Short-container-title:Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

Author:

HIDA Noriko¹,NAKAJIMA Takako²,UEMURA Naoto³,IWAI Takaaki⁴,WATANABE Noriko⁴,KANOU Takesh⁵,KAWASHIRO Takashi⁵,MASUDA Noriyuki⁶

Affiliation:

1. Department of Clinical Pharmacy, Division of Clinical Research and Development, School of Pharmacy, Showa University,Japan

2. Department of Early Clinical Development, Kyoto University Graduate School of Medicine, Japan

3. Faculty of Medicine Department of Clinical Pharmacology & Therapeutics, Oita University, Japan

4. Pharmaceutical Research Laboratories, Pharmaceuticals Group, Life Science Business Unit, NIPPON KAYAKU Co., Ltd., Japan

5. Pharmaceutical Development Division, Pharmaceuticals Group, Life Science Business Unit, NIPPON KAYAKU Co., Ltd., Japan

6. Izumi City General Hospital, Japan

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Link

Reference17 articles.

1. 1) 医薬品インタビューフォーム．タルセバ^®錠25 mg／タルセバ^®錠100 mg／タルセバ^®錠150 mg （2022年2月改訂，第17版）

2. 2) 厚生労働省医薬安全局．後発医薬品の生物学的同等性試験ガイドラインについて．［https://www.nihs.go.jp/drug/be-guide/GL971222_BE.pdf （accessed 2023-11-21）］

3. 3) 厚生労働省医薬食品局．後発医薬品の生物学的同等性試験ガイドライン等の一部改正について．［https://www.japal.org/wp-content/uploads/mt/20120229_0229-10.pdf （accessed 2023-11-21）］