Clinical pharmacology and therapeutics

Keyphrases

Publications

volume 116, number 2, 2024

William B Feldman, Leah Zoe Gibson Rand, Daniel Carpenter, Massimiliano Russo, Anushka Bhaskar, Zhigang Lu, Eric G Campbell, Jonathan Darrow, Aaron S Kesselheim
Trust in the Food and Drug Administration: A National Survey Study. Clinical pharmacology and therapeutics 116 (2) (2024)
Linas Krulikas, Jill S Bates, Catherine Chanfreau, Heather Coleman, Shawn Dalton, Deepak Voora
Association of Pharmacogenomic Phenotypes in CYP2D6, CYP2C9, CYP2C19, and CYP3A5 on Polypharmacy in Veterans. Clinical pharmacology and therapeutics 116 (2) (2024)
Stuart Friedrich, Laiyi Chua, David H Adams, Wallace Crandall, Xin Cindy Zhang
Mirikizumab Exposure-Response Relationships in Patients with Moderately-to-Severely Active Ulcerative Colitis in Randomized Phase II and III Studies. Clinical pharmacology and therapeutics 116 (2) (2024)
Xiaozhi Liao, Timothy Qi, Jiawei Zhou, Can Liu, Yanguang Cao
Optimizing Clinical Translation of Bispecific T-cell Engagers through Context Unification with a Quantitative Systems Pharmacology Model. Clinical pharmacology and therapeutics 116 (2) (2024)
Luana Colloca, Evelina Mocci, Yang Wang, Rachel Massalee, Shuo Chen, Jewel White, Kesha Johnson, Gloria M Patron Fidalgo, Gerald M Wilson, David Goldman, Susan G Dorsey
Transcriptomic Profiles Associated with Experimental Placebo Effects in Chronic Pain. Clinical pharmacology and therapeutics 116 (2) (2024)
Zhi-Rong Yang, Hua He, Rui Wang, Dongyang Liu, Ge Li, Feng Sun
Application and Quality of Model-Based Meta-Analysis in Pharmaceutical Research: A Systematic Cross-Sectional Analysis and Practical Considerations. Clinical pharmacology and therapeutics 116 (2) (2024)

volume 116, number 3, 2024

Ming-Lung Tsai, Yuan Lin, Dong-Yi Chen, Ming-Shyan Lin, Chao-Yung Wang, I-Chang Hsieh, Ning-I Yang, Ming-Jui Hung, Tien-Hsing Chen
Ticagrelor versus Adjusted-Dose Prasugrel in Acute Coronary Syndrome with Percutaneous Coronary Intervention. Clinical pharmacology and therapeutics 116 (3) (2024)
Roberto Viviani, Judith Berres, Julia Carolin Stingl
Phenotypic Models of Drug-Drug-Gene Interactions Mediated by Cytochrome Drug-Metabolizing Enzymes. Clinical pharmacology and therapeutics 116 (3) (2024)
Anne-Kristina Mercier, Sebastian Ueckert, Mikael Sunnåker, Bengt Hamrén, Philip Ambery, Peter J Greasley, Magnus Åstrand
From Plan to Pivot: How Model-Informed Drug Development Shaped the Dose Strategy of the Zibotentan/Dapagliflozin ZENITH Trials. Clinical pharmacology and therapeutics 116 (3) (2024)
Arthur Geraud, David Combarel, Christian Funck-Brentano, Quentin Beaulieu, Noël Zahr, Sophie Broutin, Jean-Philippe Spano, Christophe Massard, Benjamin Besse, Paul Gougis
A Score to Predict the Clinical Usefulness of Therapeutic Drug Monitoring: Application to Oral Molecular Targeted Therapies in Cancer. Clinical pharmacology and therapeutics 116 (3) (2024)
Jules M Janssen Daalen, Djoeke Doesburg, Liesbeth Hunik, Rogier Kessel, Thomas Herngreen, Dennis Knol, Thony Ruys, Bartholomeus J F van den Bemt, Henk J Schers
Model-Informed Precision Dosing Using Machine Learning for Levothyroxine in General Practice: Development, Validation and Clinical Simulation Trial. Clinical pharmacology and therapeutics 116 (3) (2024)
Ronaldo Morales Junior, Victor Amajor, Kelli Paice, Kathryn E Kyler, Horace Rhodes Hambrick, Kathryn E Pavia, Andrew S Haynes, Felicia Gooden, Gwendolyn M Pais, Kevin James Downes, Laura B Ramsey, Jonathan B Wagner, Sonya C Tang Girdwood
From Dose to Exposure: Shifting the Paradigm of Pediatric Clinical Pharmacology Research and Education. Clinical pharmacology and therapeutics 116 (3) (2024)
Nam Atiqur Rahman, Mirat Shah, Stacy S Shord
Dosage Optimization: A Regulatory Perspective for Developing Oncology Drugs. Clinical pharmacology and therapeutics 116 (3) (2024)
Mohamed A Kamal, Samit Ganguly, Ananth Kadambi, Patrick F Smith
Extended Model-Informed Drug Development: Beyond Clinical Trials and Regulatory Approval. Clinical pharmacology and therapeutics 116 (3) (2024)
Sara Belli, Maria Amann, Lucy Hutchinson, Laurène Pousse, Afsaneh Abdolzade-Bavil, Nicole Justies, Bjoern Jacobsen, Corinne Ploix, Eleni Tselempi, Vinko Tosevski, Hans Koll, Gabriel Schnetzler, Christophe Boetsch, Estelle Marrer-Berger
Optimizing Early Clinical Investigations in Cancer Immunotherapy: The Translational Journey of RG6292, a Novel, Selective Treg-Depleting Antibody. Clinical pharmacology and therapeutics 116 (3) (2024)
Divya Samineni, Karthik Venkatakrishnan, Ahmed A Othman, Yazdi K Pithavala, Srinivasu Poondru, Chirag Patel, Pavan Vaddady, Wendy Ankrom, Saroja Ramanujan, Nageshwar Budha, Michael Wu, Nahor Haddish-Berhane, Holger Fritsch, Azher Hussain, Jitendra Kanodia, Meng Li, Mengyao Li, Murad Melhem, Apurvasena Parikh, Vijay V Upreti, Neeraj Gupta
Dose Optimization in Oncology Drug Development: An International Consortium for Innovation and Quality in Pharmaceutical Development White Paper. Clinical pharmacology and therapeutics 116 (3) (2024)
Anna M Mc Laughlin, Thomas Helland, Fenja Klima, Stijn L W Koolen, Ron H N van Schaik, Ron H J Mathijssen, Patrick Neven, Jesse Joachim Swen, Henk-Jan Guchelaar, Florence Dalenc, Melanie White-Koning, Robin Michelet, Gerd Mikus, Werner Schroth, Thomas Mürdter, Hiltrud B Brauch, Matthias Schwab, Håvard Søiland, Gunnar Mellgren, Fabienne Thomas, Charlotte Kloft, Daniel Louis Hertz, null null
Nonlinear Mixed-Effects Model of Z-Endoxifen Concentrations in Tamoxifen-Treated Patients from the CEPAM Cohort. Clinical pharmacology and therapeutics 116 (3) (2024)
Karen Rowland Yeo, Eva Gil Berglund, Yuan Chen
Dose Optimization Informed by PBPK Modeling: State-of-the Art and Future. Clinical pharmacology and therapeutics 116 (3) (2024)
Zachary L Taylor, Francis G Green, Nayeem Hossain, Gilbert J Burckart, Michael Pacanowski, Robert N Schuck
Assessment of Dosing Strategies for Pediatric Drug Products. Clinical pharmacology and therapeutics 116 (3) (2024)
Peng Zou, Hamim Zahir, Anil Duggal, Grishma Pandya, James Jin, Tarek A Leil
Pharmacokinetics, Pharmacodynamics, and Safety of Edoxaban in Pediatric Subjects: A Phase I Single-Dose Study. Clinical pharmacology and therapeutics 116 (3) (2024)
Mineo Matsumoto, Joseph Ryan Polli, Suresh K Swaminathan, Kaushik Datta, Cris Kampershroer, Marie C Fortin, Smita Salian-Mehta, Rutwij Dave, Zheng Yang, Payal Arora, Masanori Hiura, Mizuho Suzuki, Frank R Brennan, Jean Sathish
Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno-Safety Technical Committee (ITC). Clinical pharmacology and therapeutics 116 (3) (2024)
Iris K Minichmayr, Mohamad Shebley, Piet H van der Graaf, Karthik Venkatakrishnan
Getting the Dosage Right: A Vital Role for Clinical Pharmacology in the Era of Precision Medicine. Clinical pharmacology and therapeutics 116 (3) (2024)
Jie En Valerie Sia, Xuan Lai, Wen Yao Mak, Xinyi Wu, Fan Zhang, Dongyang Liu, Dongyang Liu, Xiaoqiang Xiang
Aging-Related CYP3A Functional Changes in Chinese Older Patients: New Findings from Model-Based Assessment of Amlodipine. Clinical pharmacology and therapeutics 116 (3) (2024)
Mohamed Elmeliegy, Joseph Chen, Aruna Dontabhaktuni, Allison Gaudy, Georgi I Kapitanov, Junyi Li, Sabiha R Mim, Sharad Sharma, Qin Sun, Sihem Ait-Oudhia
Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific T-Cell Engagers Development in Oncology. Clinical pharmacology and therapeutics 116 (3) (2024)
Undine Falkenhagen, Larisa H Cavallari, Julio D Duarte, Charlotte Kloft, Stephan Schmidt, Wilhelm Huisinga
Leveraging QSP Models for MIPD: A Case Study for Warfarin/INR. Clinical pharmacology and therapeutics 116 (3) (2024)
Kine Eide Kvitne, Jøran Hjelmesæth, Markus Herberg Hovd, Rune Sandbu, Line Kristin Johnson, Shalini Andersson, Cecilia Karlsson, Hege Christensen, Rasmus Jansson-Löfmark, Anders Asberg, Ida Robertsen
Oral Drug Dosing After Gastric Bypass and Diet-Induced Weight Loss: Simpler Than We Think? Lessons Learned From the COCKTAIL Study. Clinical pharmacology and therapeutics 116 (3) (2024)
Brian Kiesel, Mayu Osawa, Madhan Masilamani, Merav Bar, Kevin Hsu, Colin Godwin, Michael Burgess, Manisha Lamba, Allison Gaudy
Informing the Recommended Phase III Dose of Alnuctamab, a CD3 × BCMA T-Cell Engager, Using Population Pharmacokinetics and Exposure-Response Analysis. Clinical pharmacology and therapeutics 116 (3) (2024)
Amin Rostami-Hodjegan, Zubida M Al-Majdoub, Yannick von Grabowiecki, Ka Lai Yee, Sudhakar Sahoo, Wolfgang Breitwieser, Aleksandra Galetin, Christopher Gibson, Brahim Achour
Dealing With Variable Drug Exposure Due to Variable Hepatic Metabolism: A Proof-of-Concept Application of Liquid Biopsy in Renal Impairment. Clinical pharmacology and therapeutics 116 (3) (2024)
Mariam A Ahmed, Hazem E Hassan
Getting the Dose Right: ASCPT Translational Precision Medicine (TPM) Network Perspectives. Clinical pharmacology and therapeutics 116 (3) (2024)
Ronaldo Morales Junior, Victor Amajor, Kelli Paice, Kathryn E Kyler, Horace Rhodes Hambrick, Kathryn E Pavia, Andrew S Haynes, Felicia Gooden, Gwendolyn M Pais, Kevin James Downes, Laura B Ramsey, Jonathan B Wagner, Sonya C Tang Girdwood
From Dose to Exposure: Shifting the Paradigm of Pediatric Clinical Pharmacology Research and Education. Clinical pharmacology and therapeutics 116 (3) (2024)
Amer Al-Khouja, Nadia Chaudhri, Ergun Velidedeoglu, Ozlem Belen, Youwei Bi, Suresh Doddapaneni, Jianmeng Chen
Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in Pediatric Recipients of Heart or Liver Transplants: A Regulatory Perspective. Clinical pharmacology and therapeutics 116 (3) (2024)
Anders Thorsted, Chiara Zecchin, Alienor Berges, Mats O Karlson, Lena E Friberg
Predicting the Long-Term Effects of Therapeutic Neutralization of Oncostatin M on Human Hematopoiesis. Clinical pharmacology and therapeutics 116 (3) (2024)
Sandhya Mandlekar, Dhruvitkumar S Sutaria, Xiaoyun Yang, Ryan Johnson, Yixuan Zou, Brian Dean, Liuxi Chen, Rucha Sane, Kathi Williams, Alison Cardenas, Mary Simon, Saloumeh Fischer
Evaluation of Patient-Centric Sample Collection Technologies for Pharmacokinetic Assessment of Large and Small Molecules. Clinical pharmacology and therapeutics 116 (3) (2024)
Mark J Ratain
Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer. Clinical pharmacology and therapeutics 116 (3) (2024)
Judith Y M N Derijks-Engwegen, Nynke G L Jager
Dosing and Exposure of Vancomycin With Continuous Infusion: A Retrospective Study. Clinical pharmacology and therapeutics 116 (3) (2024)
Susan M Abdel-Rahman, Andrew J Farrell, N Seth Berry, Gilbert J Burckart
Optimizing Dosage in Pharmacotherapy-Missing the Forest for the Trees. Clinical pharmacology and therapeutics 116 (3) (2024)
Thomas M Polasek, Richard Wilson Peck
Beyond Population-Level Targets for Drug Concentrations: Precision Dosing Needs Individual-Level Targets that Include Superior Biomarkers of Drug Responses. Clinical pharmacology and therapeutics 116 (3) (2024)
Neha Thakre, Aline Goebel, Insa Winzenborg, Ahmed A Suleiman, Ronilda R D'Cunha, Sven Mensing, Wei Liu, Yinuo Pang
Population Pharmacokinetic and Exposure-Response Modeling to Inform Risankizumab Dose Selection in Patients With Ulcerative Colitis. Clinical pharmacology and therapeutics 116 (3) (2024)
Jessica Wojciechowski, Arnab Mukherjee, Christopher Banfield, Timothy Nicholas
Model-Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate-to-Severe Ulcerative Colitis. Clinical pharmacology and therapeutics 116 (3) (2024)
Ronaldo Morales Junior, Victor Amajor, Kelli Paice, Kathryn E Kyler, Horace Rhodes Hambrick, Kathryn E Pavia, Andrew S Haynes, Felicia Gooden, Gwendolyn M Pais, Kevin James Downes, Laura B Ramsey, Jonathan B Wagner, Sonya C Tang Girdwood
From Dose to Exposure: Shifting the Paradigm of Pediatric Clinical Pharmacology Research and Education. Clinical pharmacology and therapeutics 116 (3) (2024)
Zachary L Taylor, Francis G Green, Nayeem Hossain, Gilbert J Burckart, Michael Pacanowski, Robert N Schuck
Assessment of Dosing Strategies for Pediatric Drug Products. Clinical pharmacology and therapeutics 116 (3) (2024)
Ronaldo Morales Junior, Victor Amajor, Kelli Paice, Kathryn E Kyler, Horace Rhodes Hambrick, Kathryn E Pavia, Andrew S Haynes, Felicia Gooden, Gwendolyn M Pais, Kevin James Downes, Laura B Ramsey, Jonathan B Wagner, Sonya C Tang Girdwood
From Dose to Exposure: Shifting the Paradigm of Pediatric Clinical Pharmacology Research and Education. Clinical pharmacology and therapeutics 116 (3) (2024)
Iris K Minichmayr, Tomoyuki Mizuno, Srijib Goswami, Richard Wilson Peck, Thomas M Polasek, null null
Recent Advances Addressing the Challenges of Precision Dosing. Clinical pharmacology and therapeutics 116 (3) (2024)
Zachary L Taylor, Francis G Green, Nayeem Hossain, Gilbert J Burckart, Michael Pacanowski, Robert N Schuck
Assessment of Dosing Strategies for Pediatric Drug Products. Clinical pharmacology and therapeutics 116 (3) (2024)
David Combarel, Arthur Geraud, Paul Gougis
Reply to: "Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer" and "Therapeutic Drug Monitoring of Oral Oncology Drugs: Finding the Right Nails". Clinical pharmacology and therapeutics 116 (3) (2024)
Elena Maria Tosca, Alessandro De Carlo, Davide Ronchi, Paolo Magni
Model-Informed Reinforcement Learning for Enabling Precision Dosing Via Adaptive Dosing. Clinical pharmacology and therapeutics 116 (3) (2024)
Niels A D Guchelaar, Maud B A van der Kleij, Neeltje Steeghs, Alwin D R Huitema, Ron H J Mathijssen, Stijn L W Koolen
Therapeutic Drug Monitoring of Oral Oncology Drugs: Finding the Right Nails. Clinical pharmacology and therapeutics 116 (3) (2024)
Robin Thomas Ulrich Haid, Andreas Reichel
Transforming the Discovery of Targeted Protein Degraders: The Translational Power of Predictive PK/PD Modeling. Clinical pharmacology and therapeutics 116 (3) (2024)
Diane R Mould, Richard N Upton
"Getting the Dose Right"-Revisiting the Topic With Focus on Biologic Agents. Clinical pharmacology and therapeutics 116 (3) (2024)
Allison M Claas, Meelim J Lee, Pai-Hsi Huang, Charles G Knutson, Domenico Bullara, Birgit Schoeberl, Suzanne Gaudet
Viral Kinetics Model of SARS-CoV-2 Infection Informs Drug Discovery, Clinical Dose, and Regimen Selection. Clinical pharmacology and therapeutics 116 (3) (2024)