Clinical pharmacology in drug development

Keyphrases

Publications

volume 13, number 6, 2024

Yunfei Li, Hua Zhang, Hitesh Pandya, Liyan Miao, Fred Reid, Eulalia Jimenez, Muhammad Waqas Sadiq, Rachel Moate, Alejhandra Lei, Xiao-Hong Zhou, Chris Kell, Junjie Ding, Guanlin Zhang, Lina Zhao, Xiaoyun Ge
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability After Subcutaneous Administration of Tozorakimab in Healthy Chinese Participants. Clinical pharmacology in drug development 13 (6) (2024)
Zenglian Yue, Yin Wang, Zeng Li, Tao Jin, Yucheng Sheng
Evaluation of Bioequivalence for Avapritinib Tablets in Chinese Participants Under Fasting Conditions Using a Reference-Scaled Average Bioequivalence Method. Clinical pharmacology in drug development 13 (6) (2024)
Ramachandra Sangana, Yan Xu, Bharti Shah, Xianbin Tian, Julia Zack, Kasra Shakeri-Nejad, Sampath Kalluri, Ieuan Jones, Monica Ligueros-Saylan, Angel Fowler Taylor, Devendra Kumar Jain, Emil Scosyrev, Alkaz Uddin, Nathalie Laurent, Paola Paganoni
Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers. Clinical pharmacology in drug development 13 (6) (2024)
Elijah J Weber, Islam R Younis, Lulu Wang, Deqing Xiao, William T Barchuk, Ahmed A Othman
Evaluation of the Effects of Meal Type and Acid-Reducing Agents on the Pharmacokinetics of Cilofexor, a Selective Nonsteroidal Farnesoid X Receptor Agonist. Clinical pharmacology in drug development 13 (6) (2024)
Mong-Jen Chen, Patrick Marroum, Yi-Lin Chiu, Melina Neenan, Nael M Mostafa, Mohamad Shebley
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Product: Phase 1 Results in Healthy Pre- and Postmenopausal Women. Clinical pharmacology in drug development 13 (6) (2024)
Michael Babcock, Jianhong Zheng, Jessica Gail Shurr, Li Li, Bing Wang, Pedro Huertas, Philip John Ryan, Yuqiao Shen, Marvin Garovoy
Phase 1 Healthy Volunteer Study of AL01211, an Oral, Non-brain Penetrant Glucosylceramide Synthase Inhibitor, to Treat Fabry Disease and Type 1 Gaucher Disease. Clinical pharmacology in drug development 13 (6) (2024)

volume 13, number 7, 2024

Yang Song, Farah N Ali, Zhan Ye, Jennifer Zarzoso, John Rogowski, Yajing Sun, Yan Xin
Pharmacokinetics of Fipaxalparant, a Small-Molecule Selective Negative Allosteric Modulator of Lysophosphatidic Acid Receptor 1, and the Effect of Food in Healthy Volunteers. Clinical pharmacology in drug development 13 (7) (2024)
Xiaoxu Wang, Hongzhong Liu, Cheng Cui, Xiaoye Niu, Haiyan Li, Shu Niu, Pangke Yan, Nan Wu, Fangqiong Li, Qinghe Wu, Kai Chen, Bei Hu, Dongyang Liu
Concentration-QTc Modeling of the DPP-4 Inhibitor HSK7653 in a First-in-Human Study of Chinese Healthy Volunteers. Clinical pharmacology in drug development 13 (7) (2024)
Yang Song, Farah N Ali, Zhan Ye, Jennifer Zarzoso, John Rogowski, Yajing Sun, Yan Xin
Pharmacokinetics of Fipaxalparant, a Small-Molecule Selective Negative Allosteric Modulator of Lysophosphatidic Acid Receptor 1, and the Effect of Food in Healthy Volunteers. Clinical pharmacology in drug development 13 (7) (2024)
Alessandra Cipriano, Ram P Kapil, Mingyan Zhou, Manjunath S Shet, Garth T Whiteside, Sandra K Willsie, Stephen C Harris
Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-Ascending Doses of Sunobinop in Healthy Participants. Clinical pharmacology in drug development 13 (7) (2024)
Akihito Ogasawara, Ryosuke Ide, Shinsuke Inoue, Renli Teng, Atsuhiro Kawaguchi
Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist. Clinical pharmacology in drug development 13 (7) (2024)
Michiel de Vries, Susanne Bonsmann, Jörg Pausch, Melanie Sumner, Alexander Birkmann, Holger Zimmermann, Dirk Kropeit
Evaluation of the Clinical Drug-Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach. Clinical pharmacology in drug development 13 (7) (2024)
Michiel de Vries, Susanne Bonsmann, Jörg Pausch, Melanie Sumner, Alexander Birkmann, Holger Zimmermann, Dirk Kropeit
Evaluation of the Clinical Drug-Drug Interaction Potential of Pritelivir on Transporters and CYP450 Enzymes Using a Cocktail Approach. Clinical pharmacology in drug development 13 (7) (2024)
Mohamed-Eslam F Mohamed, Yuli Qian, Ronilda D'Cunha, Shuai Hao, Roberto Carcereri De Prati, Gweneth F Levy, Kinjal Hew, Wei Liu
Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults. Clinical pharmacology in drug development 13 (7) (2024)
Akihito Ogasawara, Ryosuke Ide, Shinsuke Inoue, Renli Teng, Atsuhiro Kawaguchi
Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist. Clinical pharmacology in drug development 13 (7) (2024)
Peiying Zuo, Million Arefayene, Wei-Jian Pan, Tomoko Freshwater, Jonathan Monteleone
A Population Pharmacokinetic Assessment of the Effect of Food on Selumetinib in Patients with Neurofibromatosis Type 1-Related Plexiform Neurofibromas and Healthy Volunteers. Clinical pharmacology in drug development 13 (7) (2024)
Fangfang Wang, Xiaoye Niu, Fei Liu, Xifeng Ma, Fang Cheng, Haiyan Xu, Li Wang, Yanjun Xu, Haiyan Li
Safety, Tolerability, and Pharmacokinetics of Anaprazole, a Novel Proton Pump Inhibitor, in Healthy Chinese Subjects. Clinical pharmacology in drug development 13 (7) (2024)
Fangfang Wang, Xiaoye Niu, Fei Liu, Xifeng Ma, Fang Cheng, Haiyan Xu, Li Wang, Yanjun Xu, Haiyan Li
Safety, Tolerability, and Pharmacokinetics of Anaprazole, a Novel Proton Pump Inhibitor, in Healthy Chinese Subjects. Clinical pharmacology in drug development 13 (7) (2024)
Chenning Zhang, Rui Liang, Dejie Liu, Xianghua Wang, Shuhua Yang, Qingwen Hu, Qing Wen, Hengli Zhao
Pharmacokinetics of Nitazoxanide Dry Suspensions After Single Oral Doses in Healthy Subjects: Food Effects Evaluation and Bioequivalence Study. Clinical pharmacology in drug development 13 (7) (2024)
Ekaterina Koksharova, Roman Drai, Sergei Noskov, Artem Dorotenko, Ekaterina Protsenko, Kseniia Radaeva, Anna Arefeva, Maria Gefen, Gagik Galstyan, Igor Makarenko
Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic-Euglycemic Clamp Procedure. Clinical pharmacology in drug development 13 (7) (2024)
Alexandre Duong, Amélie Marsot
Nlmixr2 Versus NONMEM: An Evaluation of Maximum A Posteriori Bayesian Estimates Following External Evaluation of Gentamicin and Tobramycin Population Pharmacokinetic Models. Clinical pharmacology in drug development 13 (7) (2024)
Alessandra Cipriano, Ram P Kapil, Mingyan Zhou, Manjunath S Shet, Garth T Whiteside, Sandra K Willsie, Stephen C Harris
Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-Ascending Doses of Sunobinop in Healthy Participants. Clinical pharmacology in drug development 13 (7) (2024)
Panli Cardona, Sandeep Dutta, Brett Houk
Effect of Strong CYP3A4 Inhibition, CYP3A4 Induction, and OATP1B1/3 Inhibition on the Pharmacokinetics of a Single Oral Dose of Sotorasib. Clinical pharmacology in drug development 13 (7) (2024)
Ekaterina Koksharova, Roman Drai, Sergei Noskov, Artem Dorotenko, Ekaterina Protsenko, Kseniia Radaeva, Anna Arefeva, Maria Gefen, Gagik Galstyan, Igor Makarenko
Clinical Pharmacology of GP40321 (Insulin Glulisine Biosimilar): Pharmacokinetic and Pharmacodynamic Comparability in a Hyperinsulinemic-Euglycemic Clamp Procedure. Clinical pharmacology in drug development 13 (7) (2024)
Xiaoxu Wang, Hongzhong Liu, Cheng Cui, Xiaoye Niu, Haiyan Li, Shu Niu, Pangke Yan, Nan Wu, Fangqiong Li, Qinghe Wu, Kai Chen, Bei Hu, Dongyang Liu
Concentration-QTc Modeling of the DPP-4 Inhibitor HSK7653 in a First-in-Human Study of Chinese Healthy Volunteers. Clinical pharmacology in drug development 13 (7) (2024)
Mohamed-Eslam F Mohamed, Yuli Qian, Ronilda D'Cunha, Shuai Hao, Roberto Carcereri De Prati, Gweneth F Levy, Kinjal Hew, Wei Liu
Pharmacokinetics, Safety, and Tolerability of Cedirogant in Healthy Japanese and Chinese Adults. Clinical pharmacology in drug development 13 (7) (2024)

volume 13, number 8, 2024

Fang Yang, Yongying Lu, Lihui Bai, Chenhui Deng, Zhen Liu, Zhihua Sun, Li Li, Shicong Wang, Li Zhou, Haifeng Feng, Shaoyu Yan, Jiman Zhu
Population Pharmacokinetics and Exposure-Response Relationship of Zimberelimab in Chinese Patients with Advanced Tumors. Clinical pharmacology in drug development 13 (8) (2024)
Thalita Martins da Silva, Marcelo Gomes Davanço, Jessica Meulman, Débora Renz Barreto Vianna, Fernando Costa, Fernando Bastos Canton Pacheco, Silvana Aparecida Calafatti Carandina, Eduardo Issa, Celso Francisco Pimentel Vespasiano
Tramadol/Diclofenac Fixed-Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product. Clinical pharmacology in drug development 13 (8) (2024)
Chuei Wuei Leong, Kar Ming Yee, Ivan Liew, Nur Athirah Khaleb, Shahnun Ahmad, Tracy Ann Rani, Kheng Jim Lau, Danang Agung Yunaidi, Ronal Simanjuntak, Vicky A Ginanjar
Apixaban Pharmacokinetics and Bioequivalence of Two Tablet Formulations: A Randomized, Open-Label, Crossover Study, Fasting Condition in Healthy Indonesian Volunteers. Clinical pharmacology in drug development 13 (8) (2024)
Pharavee Jaiprasart, Peter Hellemans, Juhui James Jiao, Anne-Gaëlle Dosne, Marc De Meulder, Loeckie De Zwart, Laurane Brees, Wei Zhu
Effect of Carbamazepine on the Pharmacokinetics of Erdafitinib in Healthy Participants. Clinical pharmacology in drug development 13 (8) (2024)
Jae Hoon Kim, Jang Hee Hong, Jin-Gyu Jung, Won Tae Jung, Kyu-Yeol Nam, Jae Seok Roh, Youn Woong Choi, Junbae Bang, Hyunwook Huh, Hye J Lee, JungHa Moon, Jaehee Kim, Jung Sunwoo
Pharmacokinetic and Safety Comparison of Fixed-Dose Combination of Cilostazol/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults. Clinical pharmacology in drug development 13 (8) (2024)
Allan M Evans, Gianfranco Fornasini, Tahlia R Meola, William A Gahl, Marjan Huizing, Thomas M Polasek, Stephanie E Reuter
Impact of Food on the Oral Absorption of N-Acetyl-D-Mannosamine in Healthy Men and Women. Clinical pharmacology in drug development 13 (8) (2024)
Yumin Li, Zhen Zhang, Jizhen Xie, Xianghua Lian, Guangtao Zhang, Cheng Wang
Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions. Clinical pharmacology in drug development 13 (8) (2024)
Yongtao Li, Yingying Huang, Xihua Fu, Jiajing Xia, Jianfen Su, Wenzhao Gu, Weixiong Liu, Jianqing Jian, Zuoheng Xu
Bioequivalence Study of Atenolol Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions. Clinical pharmacology in drug development 13 (8) (2024)
Ramesh Boinpally, Lisa Borbridge, Veronica Wangsadipura
Pharmacokinetics and Safety of Atogepant Co-administered with Quinidine Gluconate in Healthy Participants: A Phase 1, Open-Label, Drug-Drug Interaction Study. Clinical pharmacology in drug development 13 (8) (2024)
Sheng He, Xinyi Wu, Wanggang Zhang, Keli Wang, Yu Chen, Zhibo Zheng, Ting Zhang, Lili Chen, Qingqing Duan, Dongyuan He, Binbin Wu
Pharmacokinetics and Bioequivalence of Vardenafil Hydrochloride in Healthy Chinese Volunteers. Clinical pharmacology in drug development 13 (8) (2024)
Chenna Keshava Reddy Sannala, Carol MacLean, Finn Larsen, Steve van Os, Pravin Jadhav, Neal Shore, Alicia K Morgans, Tochukwu Okwuosa, Joga Gobburu
A Model-Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk. Clinical pharmacology in drug development 13 (8) (2024)
Chuei Wuei Leong, Kar Ming Yee, Tracy Ann Rani, Kheng Jinm Lau, Shahnun Ahmad, Atiqah Amran, Farah Wahidah Mohd Hassan, Naveen Kumar
Pharmacokinetics and Bioequivalence of Fixed-Dose Combination of Simvastatin and Ezetimibe Tablets: A Randomized, Crossover, Open-Label Study in Healthy Volunteers. Clinical pharmacology in drug development 13 (8) (2024)

volume 13, number 9, 2024

Matthew W Hruska, Mary Ann Mascelli, Sam Liao, Lori Liao, Patrick Davies, Jennifer Kong, Douglas A Marsteller
Population Pharmacokinetics of Naloxegol in Pediatric Subjects Receiving Opioids. Clinical pharmacology in drug development 13 (9) (2024)
Graham Devereux, Marcin Bula, Karen Tripp, Richard Fitzgerald, Nicola Eraut, Muhammad Salman Alam, Tomoyuki Moriyama, Raku Shinkyo, Lauren Walker, Duolao Wang, Fabian Gusovsky, Jeannette van der Velde, Joseph D Turner, Weiqian David Hong, Paul M O'Neill, Mark J Taylor, Stephen A Ward
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti-Wolbachia Candidate Macrofilaricide. Clinical pharmacology in drug development 13 (9) (2024)
Hans Lennernäs, Magnus Brisander, Charlotta Liljebris, Gérald Jesson, Per Andersson
Enhanced Bioavailability and Reduced Variability of Dasatinib and Sorafenib with a Novel Amorphous Solid Dispersion Technology Platform. Clinical pharmacology in drug development 13 (9) (2024)
Sven Stodtmann, Mong-Jen Chen, Ana Victoria Ponce-Bobadilla, Tricia K Finney-Hayward, Jasmina Kalabic, Nael M Mostafa
SERENE ER Analysis Part 2 SERENE-UC: Exposure-response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients with Moderately to Severely Active Ulcerative Colitis. Clinical pharmacology in drug development 13 (9) (2024)
Shichang Miao, Pablo Suso, John A Furst, Matthew G Hudson, Ashit Trivedi
Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Avacopan, a Small-Molecule Complement C5a Receptor Antagonist, for the Treatment of Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis. Clinical pharmacology in drug development 13 (9) (2024)
Shichang Miao, Pirow Bekker, Danielle Armas, Mary Lor, Ryuzo Hanada, Shota Okamura, Yuko Umezawa, Ashit Trivedi
Food Effect and Pharmacokinetic Bridging of Avacopan in Caucasian and Japanese Healthy Participants. Clinical pharmacology in drug development 13 (9) (2024)
Yin-Ming Kuo, Jeffrey S Barrett
Consideration of the Root Causes in Candidate Attrition During Oncology Drug Development. Clinical pharmacology in drug development 13 (9) (2024)
Xiang Li, Wenqiang Guo, Jian Chen, Gewen Tan
The Bioequivalence of Abexinostat (CRA-024781) Tosylate Tablets (20 mg) in Chinese Healthy Subjects Under Fasting Conditions. Clinical pharmacology in drug development 13 (9) (2024)
Abraham I J Gajardo Cortez, José Lillo-Moya, Daniel San-Martín-Martinez, Josue Pozo-Martinez, Pablo Morales, Juan C Prieto, Rubén Aguayo, Ángel Puentes, Cristobal Ramos, Solange Silva, Mabel Catalán, Karla Ramos, Claudio Olea-Azar, Ramón Rodrigo
Safety and Pharmacokinetics of a Combined Antioxidant Therapy against Myocardial Reperfusion Injury: A Phase 1 Randomized Clinical Trial in Healthy Humans. Clinical pharmacology in drug development 13 (9) (2024)
Aimen El Orche, Choukri El Khabbaz, Amine Cheikh, Houda Bouchafra, Samira Jawhari, Faouzi My El Abbes, Yahya Cherrah
Comparative Bioequivalence Study of 2 Clopidogrel 75-mg Tablet Formulations in Moroccan Volunteers. Clinical pharmacology in drug development 13 (9) (2024)
Nicholas Favatella, David Dalton, Wonkyung Byon, Samira J Merali, Christian Klem
Clinical Implications of Co-administering Apixaban with Key Interacting Medications. Clinical pharmacology in drug development 13 (9) (2024)
Mong-Jen Chen, Ana Victoria Ponce-Bobadilla, Sven Stodtmann, Alexandra P Song, Tricia K Finney-Hayward, Nael M Mostafa
SERENE ER Analysis Part 1-SERENE CD: Exposure-Response Analysis of Higher Versus Standard Adalimumab Dosing Regimens for Patients With Moderately to Severely Active Crohn Disease. Clinical pharmacology in drug development 13 (9) (2024)