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A randomized, open-label, two-cycle, two-crossover phase I clinical trial comparing the bioequivalence and safety of afatinib and Giotrif® in healthy Chinese subjects
Liu, Guangwen, Xue, Jinling, Wang, Yanli, Liu, Zhengzhi, Li, Xue, Qu, Dongmei, Su, Zhengjie, Xu, Kaibo, Qu, Xinyao, Qu, Zhaojuan, Sun, Linlin, Cao, Mingming, Wang, Ying, Chen, Xuesong, Yu, Jing, Liu, Lang, Deng, Qiaohuan, Zhao, Yicheng, Zhang, Lixiu, Yang, Haimiao
Published in Journal of cancer research and clinical oncology (01.06.2023)
Published in Journal of cancer research and clinical oncology (01.06.2023)
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Generic lamotrigine versus brand‐name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard
Ting, Tricia Y., Jiang, Wenlei, Lionberger, Robert, Wong, Jessica, Jones, Jace W., Kane, Maureen A., Krumholz, Allan, Temple, Robert, Polli, James E.
Published in Epilepsia (Copenhagen) (01.09.2015)
Published in Epilepsia (Copenhagen) (01.09.2015)
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Bioequivalence and Safety of Two Amisulpride Formulations in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open‑Label, Single‑Dose, Crossover Study
Wang, Min, Peng, Yu, Yan, Hegui, Pan, Zhixiang, Du, Ronghui, Liu, Guan
Published in Drugs in R&D (01.06.2025)
Published in Drugs in R&D (01.06.2025)
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Analysis on the Impact of U.S. FDA’s Narrow Therapeutic Index Bioequivalence Criteria on Generic Drug Applications
Anim Anno, Krista, Mina, Mirette, Zhang, Zhen, Zhang, Lei, Jiang, Wenlei
Published in The AAPS journal (12.02.2025)
Published in The AAPS journal (12.02.2025)
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Bioequivalence of cefalexin in healthy Chinese subjects
Lv, Xiaozhi, Zhong, Guoping, Yao, Herui, Wu, Junyan, Ye, Suiwen
Published in International journal of clinical pharmacology and therapeutics (01.11.2021)
Published in International journal of clinical pharmacology and therapeutics (01.11.2021)
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Bioequivalence study of voriconazole for intravenous infusion in healthy Chinese subjects under fasting conditions
Xiang, Zhangqiang, Li, Mupeng, Cui, Shaoting, Gan, Chunyan, Liu, Fangfang, Huang, Qian, Mai, Gang, Fan, Lianlian
Published in Journal of pharmaceutical sciences (01.02.2025)
Published in Journal of pharmaceutical sciences (01.02.2025)
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Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions
Sözer, Gökçe, Nacak, Muradiye, Durucu, Erol, Martin, Wolfgang, Reinsch, Martin, Koru, Selma, Erenmemişoğlu, Aydın
Published in Scientific reports (01.07.2025)
Published in Scientific reports (01.07.2025)
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Evaluating the bioequivalence and safety of liraglutide injection versus Victoza® in healthy Chinese subjects: a randomized, open, two-cycle, self-crossover phase I clinical trial
Liu, Chao, Xu, Hongrong, Yuan, Fei, Chen, Hanjing, Sheng, Lei, Chen, Weili, Xie, Haisong, Xu, Hongmei, Li, Xuening
Published in Frontiers in pharmacology (2023)
Published in Frontiers in pharmacology (2023)
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Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling
Bego, Margareta, Patel, Nikunjkumar, Cristofoletti, Rodrigo, Rostami-Hodjegan, Amin
Published in The AAPS journal (05.01.2022)
Published in The AAPS journal (05.01.2022)
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A randomized, crossover, phase I clinical study to evaluate bioequivalence and safety of tofacitinib and Xeljanz® in Chinese healthy subjects
Xu, Zhongnan, Wang, Yanli, Liu, Zhengzhi, Zhang, Renjie, Zhou, Yannan, Yu, Jing, Lan, Jing, Liang, Wenzhong, Liu, Guangwen, Qu, Xinyao, Chen, Jiahui, Su, Zhengjie, Yu, Shuang, Cheng, Yang, Wang, Wanhua, Ren, Qing, Deng, Qiaohuan, Zhao, Yicheng, Yang, Haimiao
Published in International immunopharmacology (01.08.2022)
Published in International immunopharmacology (01.08.2022)
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Bioequivalence Analysis of Ondansetron Hydrochloride Tablets in Healthy Chinese Subjects: A Randomized, Open-Label, Two-Period Crossover Phase I Study: Bioequivalence Analysis of Ondansetron Hydrochloride Tablets
Jia, Caiyun, Zhao, Na, Song, Haojing, Hu, Yiting, Xu, Yufang, Guo, Caihui, Bai, Wanjun, Dong, Zhanjun
Published in Drugs in R&D (01.12.2024)
Published in Drugs in R&D (01.12.2024)
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Virtual Bioequivalence Assessment of Tofacitinib Once Daily Modified Release Dosage Form in Pediatric Subjects
Sagawa, Kazuko, Purohit, Vivek, Le, Vu, Hsu, Hao-Jui, Dowty, Martin E., Tse, Susanna, Chang, Cheng
Published in The AAPS journal (01.04.2025)
Published in The AAPS journal (01.04.2025)
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Bioequivalence study of perampanel oral suspension in healthy Chinese subjects under fasting and fed conditions
Li, Mupeng, Li, Yaxing, Liu, Fangfang, Huang, Qian, Yi, Xinchu, Xiao, Jing, Gan, Chunyan, Han, Yangyun, Fan, Lianlian
Published in Naunyn-Schmiedeberg's archives of pharmacology (26.03.2025)
Published in Naunyn-Schmiedeberg's archives of pharmacology (26.03.2025)
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Bioequivalence of macitentan and tadalafil given as fixed‐dose combination or single‐component tablets in healthy subjects
Grill, Simon, Bruderer, Shirin, Sidharta, Patricia N., Antonova, Mariya, Globig, Susanne, Carlson, James, Schultz, Armin, Csonka, Dénes
Published in British journal of clinical pharmacology (01.12.2020)
Published in British journal of clinical pharmacology (01.12.2020)
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A single-dose, randomized, crossover bioequivalence study of levamlodipine besilate tablets in healthy subjects
Deng, Qiaohuan, Yang, Debin, Cheng, Yang, Liu, Zhengzhi, Zhou, Yannan, Wang, Yanli, Su, Zhengjie, Yang, Haimiao
Published in Naunyn-Schmiedeberg's archives of pharmacology (01.04.2025)
Published in Naunyn-Schmiedeberg's archives of pharmacology (01.04.2025)
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Pharmacokinetics and bioequivalence of Ezetimibe tablet versus Ezetrol®:an open-label, randomized, two-sequence crossover study in healthy Chinese subjects
Sun, Feifei, Liu, Yanping, Li, Ting, Lin, Pingping, Jiang, Xin, Li, Xin, Wang, Chenjing, Gao, Xiaomeng, Ma, Yaping, Fu, Yao, Cao, Yu
Published in BMC pharmacology & toxicology (03.02.2023)
Published in BMC pharmacology & toxicology (03.02.2023)
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Assessment of Pharmacokinetics and Safety with Bioequivalence of the Nitroglycerin Sublingual Tablets of Two Formulations in Chinese Healthy Subjects: A Bioequivalence Study
Fu, Qinjiao, Huang, Chunqi, Yuan, Yuan, Wang, Yu, Zhu, Bin, Liu, Yanzhu, Tian, Fang, Xu, Xiufeng, Yang, Lei, Xu, Yingying, Wang, Ying
Published in Drugs in R&D (08.08.2025)
Published in Drugs in R&D (08.08.2025)
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Pharmacokinetic and Bioequivalence Evaluation of Prolonged-Release Octreotide Acetate Microspheres in Healthy Human Subjects
Wang, Chenjing, Li, Xin, Gu, Xingli, Hu, Haixun, Lv, Zhaoguo, Sun, Yanhua, Li, Yanzhi, Hao, Chenxi, Liu, Yanping, Fu, Yao, Yang, Qingmin, Cao, Yu
Published in Clinical pharmacology in drug development (01.07.2025)
Published in Clinical pharmacology in drug development (01.07.2025)
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