Peer, Cody J Schmidt, Keith T Arisa, Oluwatobi Richardson, William J Paydary, Koosha Goldstein, Daniel A Gulley, James L Figg, William D Ratain, Mark J
Published in
Journal of clinical pharmacology
Atezolizumab, a humanized anti-PD-L1 monoclonal antibody, was initially approved in 2016, around the same time the sponsor published the minimum serum concentration to target to maintain saturation of receptor occupancy (6 μg/mL). The initially approved dose regimen of 1200 mg every 3 weeks (q3w) was subsequently modified to 840 mg q2w or 1680 mg q...
Deng, Jiexin Wang, Yi An, Xiaokang
Published in
Journal of clinical pharmacology
Warfarin has a long record of safe and effective clinical use, and it remains one of the most commonly prescribed drugs for the prevention and treatment of thromboembolic conditions even in the era of direct oral anticoagulants (DOACs). To address its large inter-individual variability and narrow therapeutic window, the Clinical Pharmacogenetics Im...
Ferreira da Silva, Renato Silva, Ana Marta Morato, Manuela Ribeiro-Vaz, Inês Polónia, Jorge Junqueira
Published in
Journal of clinical pharmacology
Darpo, Borje Borin, Marie Ferber, Georg Galluppi, Gerald R Hopkins, Seth C Landry, Ishani Lo, Arthur Rege, Bhaskar Reyderman, Larisa Sun, Lei
...
Published in
Journal of clinical pharmacology
The International Conference on Harmonization (ICH) E14 document was revised in 2015 to allow concentration-corrected QT interval (C-QTc) analysis to be applied to data from early clinical pharmacology studies to exclude a small drug-induced effect on QTc. Provided sufficiently high concentrations of the drug are obtained in the first-in-human (FIH...
Hu, Yingying Chen, Ruijia Ye, Zhenjie Wei, Fuqun Lin, Kecan Liu, Jingfeng Zeng, Yongyi
Published in
Journal of clinical pharmacology
Lenvatinib is a novel oral angiogenesis inhibitor approved in China for the treatment of unresectable hepatocellular carcinoma (HCC) without prior systemic treatment. We described the population pharmacokinetics of lenvatinib in Chinese patients with advanced HCC and explore the potential patient characteristics associated with lenvatinib pharmacok...
Kotake, Kazumasa Mitsuboshi, Satoru Kawakami, Yasuhiro
Published in
Journal of clinical pharmacology
Farasatinasab, Maryam Nassiri, Setare
Published in
Journal of clinical pharmacology
Pa, Bhavatharini G, Shri Sanghavi Thomas, Grace Kp, Arun
Published in
Journal of clinical pharmacology
Lamotrigine is the most widely used anti-epileptic drug in pregnancy because of its low teratogenicity. However, there is an increased metabolism and clearance of lamotrigine in pregnancy contributing to suboptimal drug therapy and poor disease control, prompting the need for proactive dosage adjustments. The present study aimed to develop a pharma...
Singla, Sumeet Block, Robert
Published in
Journal of clinical pharmacology
The purpose of this study is to evaluate the development of tolerance, using a population modeling approach, in recreational marijuana users after acute pulmonary administration of tetrahydrocannabinol (THC), a primary ingredient in marijuana. A total of 85 subjects in 3 separate studies smoked marijuana cigarettes (dose = 13-49 mg) under controlle...
Honda, Taku Abe, Koichiro Oda, Minoru Harada, Fumito Maruyama, Kyohei Aoyagi, Hitoshi Miura, Ryo Konno, Kumiko Arizumi, Toshihiko Asaoka, Yoshinari
...
Published in
Journal of clinical pharmacology
Although concomitant medications have been raised as a factor affecting hemorrhage during direct oral anticoagulant (DOAC) therapy, details remain unelucidated. This study was conducted to clarify the relationship between concomitant medications with possible pharmacokinetic interactions and number of concomitant medications, and bleeding and embol...
