Results 331 to 340 of about 14,301,803 (394)

Pharmacogenetic Implementation Studies—Lessons Learned From the PREPARE Study

Clinical Pharmacology &Therapeutics, EarlyView.
The Ubiquitous Pharmacogenomics consortium (www.upgx.eu) has recently completed and published the Preemptive Pharmacogenomic Testing for Preventing Adverse Drug Reactions (PREPARE) study on the implementation of panel‐based pharmacogenetic testing. PREPARE has provided interesting lessons for the design, execution, and interpretation of future clinical
Henk‐Jan Guchelaar, Cathelijne H. van der Wouden, Lisanne E. N. Manson, Heshu Abdullah‐Koolmees, Kathrin Blagec, Tanja Blagus, Stefan Böhringer, Erika Cecchin, Ka‐Chun Cheung, Vera H. M. Deneer, Siv Jonsson, Candace Joefield‐Roka, Katja S. Just, Mats O. Karlsson, Lidija Konta, Rudolf Koopmann, Marjolein Kriek, Thorsten Lehr, Christina Mitropoulou, Victoria Rollinson, Rossana Roncato, Matthias Samwald, Elke Schaeffeler, Maria Skokou, Matthias Schwab, Daniela Steinberger, Julia C. Stingl, Roman Tremmel, Richard M. Turner, Mandy H. van Rhenen, Cristina L. Dávila‐Fajardo, Vita Dolžan, George P. Patrinos, Munir Pirmohamed, Gere Sunder‐Plassmann, Giuseppe Toffoli, Jesse J. Swen, Ubiquitous Pharmacogenomics Consortium   +37 more
wiley   +1 more source

A Pharmacometric Method for Quantitative Determination of Improvement in Body Composition and Characterization of the Exposure–Response Relationship during Treatment of Obesity with Tirzepatide

Clinical Pharmacology &Therapeutics, EarlyView.
About half of the world's population is living with overweight or obesity. Tirzepatide is an approved treatment for chronic weight management. We sought to characterize the exposure–response relationship for weight reduction in patients with overweight or obesity and quantify the associated changes in body composition.
Emmanuel Chigutsa, Lucy Her, Xiaosu Ma, Shweta Urva, Karen Schneck   +4 more
wiley   +1 more source

Continuous Intravenous Nimodipine Infusion With Ethanol as Carrier in Aneurysmal Subarachnoid Hemorrhage Does Not Result in Measurable Cerebral Ethanol Levels

Clinical Pharmacology &Therapeutics, EarlyView.
An unimpaired neurological evaluation is essential for detecting delayed cerebral ischemia (DCI) in aneurysmal subarachnoid hemorrhage (aSAH) patients. Nimodipine is currently the only drug approved for DCI prevention. Intravenous nimodipine infusion contains 23.7 vol% ethanol as an excipient, resulting in up to 45 g of ethanol being infused daily ...
Miriam M. Moser, Karl Rössler, Dorian Hirschmann, Leon Gramss, Walter Plöchl, Johannes Herta, Andrea Reinprecht, Markus Zeitlinger, Arthur Hosmann   +8 more
wiley   +1 more source

Population Pharmacokinetics and Exposure‐Response Analysis of First‐Line Osimertinib Plus Chemotherapy in Patients with EGFR‐Mutated Advanced NSCLC

Clinical Pharmacology &Therapeutics, EarlyView.
Osimertinib, a third‐generation, central nervous system‐active epidermal growth factor receptor‐tyrosine kinase inhibitor, potently and selectively inhibits epidermal growth factor receptor‐tyrosine kinase inhibitor sensitizing and T790M resistance mutations, with efficacy in epidermal growth factor receptor‐mutated non‐small cell lung cancer.
Jincheng Yang, Damilola Olabode, Aarti Sawant‐Basak, Richard Baldry, Karthick Vishwanathan, Srinivas Bachina, Alexandar Todd, Dana Ghiorghiu, Yuri Rukazenkov, Diansong Zhou, Azar Shahraz   +10 more
wiley   +1 more source

RAB19, SERPINB9P1, and Pancreatitis in Patients Taking Azathioprine in Routine Clinical Practice: Genome and Transcriptome‐Wide Association Studies

Clinical Pharmacology &Therapeutics, EarlyView.
Azathioprine is used to treat several inflammatory and autoimmune diseases. However, its use is limited by serious adverse events, including acute pancreatitis. Prior studies have found an association between the HLA region and thiopurine‐induced acute pancreatitis (TIAP); however, in clinical practice, many patients with pancreatitis do not meet this ...
Shailja C. Shah, Tyler S. Reese, Laura L. Daniel, Jacy Zanussi, Alyson L. Dickson, Puran Nepal, Ran Tao, Tyne Miller‐Fleming, Peter Straub, Jennifer Maizel, Adriana M. Hung, Wei‐Qi Wei, Elizabeth J. Phillips, Nancy J. Cox, C. Michael Stein, QiPing Feng, Cecilia P. Chung   +16 more
wiley   +1 more source

Profiling a Neo‐Antigen‐Driven Immune Response in Healthy Volunteers: A Randomized, Double‐Blind, Placebo‐Controlled Study of the KLH Challenge Model

Clinical Pharmacology &Therapeutics, EarlyView.
Novel compounds targeting the adaptive immune system are commonly initially investigated in healthy volunteers (HV). HV frequently lack constitutively expressed drug‐target engagement biomarkers, complicating the evaluation of pharmacological activity. The keyhole limpet hemocyanin (KLH) neo‐antigen challenge elicits a controlled immune response in HV ...
Micha N. Ronner, Hendrika W. Grievink, Mahdi Saghari, Michelle Osse, Thierry P.P. van den Bosch, Jeffrey Damman, Marieke L. de Kam, Jacobus Burggraaf, Naomi B. Klarenbeek, Manon A. A. Jansen, Matthijs Moerland   +10 more
wiley   +1 more source

Risk of Infections with SGLT2 Inhibitors Versus DPP4 Inhibitors: A Population‐Based Cohort Study Using Antibiotic Dispensing Data

Clinical Pharmacology &Therapeutics, EarlyView.
This study compared the number and cumulative dose of antibiotic dispensings among new users of sodium–glucose cotransporter‐2 (SGLT2) inhibitors and dipeptidyl peptidase‐4 (DPP4) inhibitors following hospital discharge in individuals with type 2 diabetes.
Maria J. Alfonso Arvez, George S. Q. Tan, Sam Wade, Zanfina Ademi, Jenni Ilomäki, J. Simon Bell   +5 more
wiley   +1 more source

Safety and Efficacy of the NMDA‐2b‐Selective Negative Allosteric Modulator BI 1569912: A Phase Ib Randomized Trial in Major Depressive Disorder

Clinical Pharmacology &Therapeutics, EarlyView.
Selective N‐methyl‐D‐aspartate receptor subunit 2b negative allosteric modulators (NR2B NAMs) are being explored as potential new treatment options for major depressive disorder (MDD). This Phase Ib, randomized, double‐blind, placebo‐controlled, parallel‐group trial was conducted in adults (N = 59) with moderate‐to‐severe MDD and insufficient response ...
Roger S. McIntyre, Gerard Sanacora, David P. Walling, Elan A. Cohen, Shishuka Malhotra, Holger Rosenbrock, Manuela Schmitz, Andreas Scholz, Sigurd D. Süssmuth, Franco De Crescenzo   +9 more
wiley   +1 more source

Emulating Six Cardiovascular Outcome Trials of Antidiabetic Drugs in Individuals with Type 2 Diabetes: Analyses Based on Real‐World Databases from Korea and Taiwan

Clinical Pharmacology &Therapeutics, EarlyView.
With the increasing volume of clinical evidence derived from large‐scale Asian real‐world data (RWD) and the growing interest in its use in regulatory decision‐making, it is important to conduct benchmarking exercises that evaluate whether studies using Asian RWD can generate similar conclusions as randomized controlled trials (RCTs).
Hwa Yeon Ko, Philip C. M. Au, Michael Chun‐Yuan Cheng, Ching‐Lung Cheung, Ahhyung Choi, Miyuki Hsing‐Chun Hsieh, Han Eol Jeong, Edward Chia‐Cheng Lai, Brian Meng‐Hsun Li, Kenneth K. C. Man, Jeremy A. Rassen, Daniel Hsiang‐Te Tsai, Shirley V. Wang, Ian C. K. Wong, Ju‐Young Shin, Sohee Park   +15 more
wiley   +1 more source