Results 131 to 140 of about 104,915 (286)

Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends

Clinical Pharmacology &Therapeutics, EarlyView.
Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer, Ellen Cannady, Filip Cuyckens, Ulrike Glaenzel, Camille Granvil, Felix Huth, Alexander D. James, Wenying Li, Céline Veau, Graeme Young, Qin Yue, Gregory S. Walker, Upendra A. Argikar, Jonathan N. Bauman, Cathy Cantalloube, Yu‐Luan Chen, Ping Kang, Patricia Moliner, Mette L. Pedersen, Isabel Piel, Simone Schadt, Hanno Schieferstein, Julia Suchomel, Shuai Wang, S. Cyrus Khojasteh   +24 more
wiley   +1 more source

Safety, Tolerability, and Pharmacokinetics of GMDTC for Cadmium Poisoning: A Randomized Phase 1a/1b Trial

Clinical Pharmacology &Therapeutics, EarlyView.
Cadmium exposure causes serious health consequences; however, there is no clinically approved antidote for cadmium poisoning. This Phase 1a/1b trial aimed to investigate safety, tolerability, and pharmacokinetics of Sodium (S)‐2‐(dithiocarboxylato((2S,3R,4R,5R)‐2,3,4,5,6‐pentahydroxyhexyl) amino)‐4‐(methylthio) butanoate (GMDTC), a novel chelating ...
Xuefeng Ren, Wei Hu, Xiaobin Deng, Rong Ma, Fang Pei, Xushen Chen, Xuemei Wang, Jixin Tang, Yan Lai, Shangming Pan, Zhiyong Zhong, Sheng Fu, Huamin Yuan, Juan Yuan, Chuntao Huang, Yuan Zeng, Xiaodong Ying, Guanghui Dong, Jinxin Zhang, Jinyuan Zhao, Kangguang Lin, Xiaojiang Tang   +21 more
wiley   +1 more source

Intravenous Lipopolysaccharide Challenge in Healthy Participants Reveals Pharmacodynamic Markers in Blood and Bone Marrow for Early‐Phase Oncology Drug Development

Clinical Pharmacology &Therapeutics, EarlyView.
Demonstrating pharmacological effects in early‐phase oncology clinical trials remains challenging, largely due to the lack of robust pharmacodynamic markers. Lipopolysaccharide (LPS) is used as an immune challenge agent in healthy participants to study drugs for autoimmune conditions.
Igor Radanović, Ingrid Tomljanović, Wieke H. Grievink, Diana R. Pereira, Michelle Osse, Peter van Balen, Maria J. Juachon, Marieke L. de Kam, Lisa Pagan, Manon A.A. Jansen, Matthijs Moerland, Jacobus J. Bosch   +11 more
wiley   +1 more source

Study of pharmacokinetic parameters and safety of the drug Duonica® in comparison with the original combination of doxylamine and pyridoxine under fed conditions

Фармакокинетика и Фармакодинамика
Aim. A comparative study of the pharmacokinetics and safety of the investigational drug Duonica®, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia) and the reference drug Diclectin®, delayed-release tablets, 10 mg + 10 mg ...
I. E. Shohin, S. M. Noskov, A. A. Globenko, N. S. Bagaeva, K. K. Karnakova, O. M. Parulya, L. N. Lutskova, A. V. Kapashin, M. A. Pasko   +8 more
doaj   +1 more source

Investigational Drugs for the Treatment of Depression (Part 2): Glutamatergic, Cholinergic, Sestrin Modulators, and Other Agents. [PDF]

Front Pharmacol, 2022
Vasiliu O.
europepmc   +1 more source

Registered Clinical Trials of Ayahuasca and DMT: A Scoping Review

Clinical Pharmacology &Therapeutics, EarlyView.
Interest in ayahuasca and its main component, N,N‐Dimethyltryptamine (DMT), has currently moved from historical and experimental use into modern clinical development. Yet, current evidence is fragmented, and systematic mapping of trial methods and design choices remains limited.
Tijana Stojanović, Kent W. Nilsson, Robert Fredriksson, Helgi B. Schiöth, Thiago C. Moulin   +4 more
wiley   +1 more source

Organoid models: Regulations and prospects for the development of investigational new drugs

Chinese Medical Journal
. Over the past decade, research associated with organoids has entered a golden era, marking a significant shift in the biomedical landscape. Organoids have been widely applied in the industrial sector and have gained recognition from regulatory ...
Huachao Li, Yin Pan, Zhibao Zheng, Renzhi Lin, Yue Pan, Lizhong Lin, Mingming Quan, Hongsheng Lu, Zhe Hu, Mingbin Zheng, Yihua Chen, Yuzhu Zhang, Sihan Zhou, Xiuyuan Hao   +13 more
doaj   +1 more source

Efficacy of the current investigational drugs for the treatment of COVID-19: a scoping review. [PDF]

Ann Med, 2021
Wadaa-Allah A, Emhamed MS, Sadeq MA, Ben Hadj Dahman N, Ullah I, Farrag NS, Negida A.   +6 more
europepmc   +1 more source

Human Experimentation: Ethics in the Consent Situation [PDF]

, 1967
Fletcher, John
core   +2 more sources

Drugs and Investigations [PDF]

BMJ, 1964
openaire   +2 more sources