THE SPECIFIC FEATURES OF THE PHASE I OF CLINICAL INVESTIGATIONS OF DRUGS by A. Y. Savchenko, G. V. Ramenskaya, V. G. Kukes

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Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents by Octavian Vasiliu

“…Many investigational drugs with antidepressant activity are currently explored in different phases of clinical research, with indications such as major depressive disorder, treatment-resistant major depression, bipolar depression, post-partum depression, and late-life depression. …”
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Adaptive designs in clinical trials: why use them, and how to run and report them by Pallmann, P, Bedding, AW, Choodari-Oskooei, B, Dimairo, M, Flight, L, Hampson, LV, Holmes, J, Mander, AP, Odondi, L, Sydes, MR, Villar, SS, Wason, JMS, Weir, CJ, Wheeler, GM, Yap, C, Jaki, T

“…Adaptive designs can be applied across all phases of clinical research, from early-phase dose escalation to confirmatory trials. …”

Public and patient involvement: a survey on knowledge, experience and opinions among researchers within a precision oncology European project by Paola Mosconi, Cinzia Colombo, Pasquale Paletta, Laura Gangeri, Chiara Pellegrini, Elena Garralda, Rosalba Miceli, Cinzia Brunelli, on behalf of CEE_DART Consortium

“…Abstract Background Patient and Public Involvement (PPI) is slowly but steadily being implemented in all phases of clinical research. As part of the European project “Building Data Rich Clinical Trials” a survey was launched to investigate the knowledge, experiences and opinions on this topic of clinicians and researchers from seven European clinical and non-clinical centers (Cancer Core Europe). …”
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Pharmacokinetic, Pharmacokinetic/Pharmacodynamic, and Safety Investigations of Lefamulin in Healthy Chinese Subjects by Yingying Hu, Qiong Wei, Xingchen Bian, Xinyi Yang, Jicheng Yu, Jingjing Wang, Haijing Yang, Guoying Cao, Xiaojie Wu, Jing Zhang

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Pharmacokinetics, safety of a single dose and multiple doses of voriconazole injection of two formulations, in Chinese healthy volunteers by Chunqi Huang, Yannan Wang, Yi Wu, Sisi Lin, Rui Hao, Jin Yu, Lu Fang, Jingjing Zhu, Di Zhao, Shengjia Tong, Yongkai Si, Tiantian Ye, Zeyu Wu, Hui Huang, Zhuoyan Wang, Ying Wang

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Safety, tolerability, pharmacokinetics, and antiviral activity of the novel core protein allosteric modulator ZM-H1505R (Canocapavir) in chronic hepatitis B patients: a randomized... by Haiyan Jia, Jiajia Mai, Min Wu, Hong Chen, Xiaojiao Li, Cuiyun Li, Jingrui Liu, Chengjiao Liu, Yue Hu, Xiaoxue Zhu, Xiuhong Jiang, Bo Hua, Tian Xia, Gang Liu, Aiyun Deng, Bo Liang, Ruoling Guo, Hui Lu, Zhe Wang, Huanming Chen, Zhijun Zhang, Hong Zhang, Junqi Niu, Yanhua Ding

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Pharmacokinetics and bioequivalence of Ezetimibe tablet versus Ezetrol®:an open-label, randomized, two-sequence crossover study in healthy Chinese subjects by Feifei Sun, Yanping Liu, Ting Li, Pingping Lin, Xin Jiang, Xin Li, Chenjing Wang, Xiaomeng Gao, Yaping Ma, Yao Fu, Yu Cao

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ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial by Yue Hu, Haijun Li, Hong Zhang, Xiaoxin Chen, Jinjun Chen, Zhongyuan Xu, Hong You, Ruihua Dong, Yun Peng, Jing Li, Xiaojiao Li, Dandan Wu, Lei Zhang, Di Cao, He Jin, Dongdong Qiu, Aruhan Yang, Jinfeng Lou, Xiaoxue Zhu, Junqi Niu, Yanhua Ding

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A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects by Hong Zhang, Xiaojiao Li, Jingrui Liu, Cuiyun Li, Min Wu, Xiaoxue Zhu, Jixuan Sun, Min Fang, Yanhua Ding

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Pharmacokinetics and safety of two Voriconazole formulations after intravenous infusion in two doses in healthy Chinese subjects by Xin Li, Chenjing Wang, Ping Shi, Yanping Liu, Ye Tao, Pingping Lin, Ting Li, Haixun Hu, Feifei Sun, Shuqin Liu, Yao Fu, Yu Cao

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LZM008, a proposed tocilizumab biosimilar: Pharmacokinetics, safety, and immunogenicity profiles compared with ACTEMRA® in Chinese healthy male subjects by Guoying Cao, Jingjing Wang, Jinjie He, Yingying Hu, Haijing Yang, Linling Que, Xianghong Gu, Jicheng Yu, Xiaojie Wu, Jufang Wu, Wei Fang, Qing He, Jing Zhang

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Association of Variability and Pharmacogenomics With Bioequivalence of Gefitinib in Healthy Male Subjects by Hong Zhang, Qingmei Li, Xiaoxue Zhu, Min Wu, Cuiyun Li, Xiaojiao Li, Chengjiao Liu, Zhenwei Shen, Yanhua Ding, Shucheng Hua

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Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subje... by Shanshan Li, Xiaojie Wu, Nanyang Li, Guoying Cao, Jingjing Wang, Yuancheng Chen, Size Li, Jinjie He, Jufang Wu, Haijing Yang, Ke Lin, Chao Qiu, Angela Liu, He Zhou, Francisco Adrian, Liang Schweizer, Wenhong Zhang, Jingwen Gu, Jing Zhang, Jing Zhang

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A novel solvent-free co-grinding preparation improves curcumin bioavailability in healthy volunteers: A single-center crossover study by Chenjing Wang, Xin Jiang, Xiaolei Zhang, Yi Xu, Li Li, Xin Li, Shanglong Wang, Ping Shi, Xiaomeng Gao, Zimin Liu, W. Dennis Clark, Yu Cao

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A phase I study to evaluate the safety, tolerability, and pharmacokinetics of a novel, potent GABA analog HSK16149 in healthy Chinese subjects by Qian Chen, Qian Chen, Qian Chen, Qingqing Wu, Qingqing Wu, Qingqing Wu, Rong Song, Rong Song, Rong Song, Yating Wang, Yating Wang, Yating Wang, Mengqi Zhang, Mengqi Zhang, Mengqi Zhang, Fangqiong Li, Weifang Zeng, Wei Wang, Wei Wang, Wei Wang, Jingying Jia, Jingying Jia, Jingying Jia, Chen Yu, Chen Yu, Chen Yu, Yanmei Liu, Yanmei Liu, Yanmei Liu

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Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone receptor antagonist, in healthy men: a randomized, double-blind, placebo-controlle... by Xin Li, Feifei Sun, Xiaolei Zhang, Pingping Lin, Kai Shen, Yu Shen, Lingyu Ma, Yu Cao, Chenjing Wang

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Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phas... by Yu-Zhou Gui, Xue-Ning Li, Jing-Xin Li, Ming-Yun Shen, Mei-Wei Zhang, Ye Cao, Hong-Rong Xu, Hui Li, Jie Cheng, Liang Pan, Ying-Lei Yi, Li-Yu Liang, Cheng-Yin Yu, Gang-Yi Liu, Chen Yu, Bi-Jie Hu, Feng-Cai Zhu, Fei Liang, Haifa Shen, Jing-Ying Jia, Hang-Wen Li, Jian Zhou, Jia Fan

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In vitro pharmacokinetics/pharmacodynamics of FL058 (a novel beta-lactamase inhibitor) combined with meropenem against carbapenemase-producing Enterobacterales by Zhiwei Huang, Zhiwei Huang, Xingchen Bian, Xingchen Bian, Yi Li, Jiali Hu, Beining Guo, Xinyi Yang, Yi Jin, Shansong Zheng, Xinmei Wang, Cong Gao, Jing Zhang, Xiaojie Wu

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Physiologically based pharmacokinetic modelling and simulation to predict the plasma concentration profile of schaftoside after oral administration of total flavonoids of Desmodium... by Xue Li, Chao Chen, Nan Ding, Tianjiao Zhang, Peiyong Zheng, Ming Yang, Ming Yang

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