Results 291 to 300 of about 484,364 (380)

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses and Dose Titration of Bexicaserin in Healthy Participants in a Randomized, Double‐Blind, Placebo‐Controlled Study

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Bexicaserin (LP352) is a selective superagonist of the 5‐hydroxytryptamine 2C (5‐HT2C) receptor currently in development for the treatment of seizures that arise from developmental and epileptic encephalopathies. This phase 1, double‐blind, placebo‐controlled multiple ascending dose (MAD) study assessed the safety, tolerability, and ...
Jonathan Williams, Rosa Chan, Chad Orevillo, Gale O'Connell, Dewey McLin, Shikha Polega, Nuggehally R. Srinivas, Randall Kaye   +7 more
wiley   +1 more source

PEGylated chitosan xerogels for localized periodontal therapy: design, characterization, and drug release. [PDF]

Sci Rep
Zafar F, Sheraz MA, Ali SA, Riaz M, Ahmed S, Kazi SH, Tariq S, Anwar Z.   +7 more
europepmc   +1 more source

Supplementing Single‐Arm Trials with External Control Arms—Evaluation of German Real‐World Data

Clinical Pharmacology &Therapeutics, EarlyView.
As single‐arm trials (SATs) are increasingly used in pharmaceutical research, the validity of such study designs needs to be critically assessed. We characterize the feasibility of supplementing SATs with real‐world data (RWD)‐derived external control arms by determining the proportion of SATs on breast cancer and amyotrophic lateral sclerosis (ALS ...
Martin Russek, Jonas Peltner, Britta Haenisch   +2 more
wiley   +1 more source

Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments

Clinical Pharmacology &Therapeutics, EarlyView.
Optimal dosing of oncological drugs is historically determined based on the “higher is better” paradigm. However, a paradigm shift in optimal dose selection has occurred in the development of new modalities, including molecularly targeted drugs, antibody drugs, and immunotherapies.
Hiroe Kitagaki, Kentaro Takeda, Kazuya Murai, Hideki Maeda   +3 more
wiley   +1 more source

Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real‐World Data Sources for Fit‐for‐Purpose Studies

Clinical Pharmacology &Therapeutics, EarlyView.
The potential of real‐world data (RWD), particularly from patient registries, has been increasingly recognized over the last decade by academia, regulators, and health technology assessment (HTA) bodies for its role in assessing a product's effectiveness and supporting regulatory submissions.
Sonia Zebachi, Julien Tanniou, Elisabeth Bakker, Sieta T. de Vries, Rossella Di Bidino, Entela Xoxi, Anna Glaser, Gianluigi Savarese, Jan Hillert, Peter G. M. Mol, Kelly Plueschke, Billy Amzal, Ghinwa Y. Hayek, Jeverson Moreira   +13 more
wiley   +1 more source

What should constitute a control condition in psychedelic drug trials? [PDF]

Nat Ment Health
Colloca L, Fava M.
europepmc   +1 more source

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

Placebo

Forum Médical Suisse ‒ Swiss Medical Forum, 2007
openaire   +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

Vitamin D Supplementation and Allergic Rhinitis: A Systematic Review and Meta-Analysis. [PDF]

Medicina (Kaunas)
Kawada K, Sato C, Ishida T, Nagao Y, Yamamoto T, Jobu K, Hamada Y, Izawa Ishizawa Y, Ishizawa K, Abe S.   +9 more
europepmc   +1 more source