Results 291 to 300 of about 181,985 (340)

Safety, Pharmacokinetics, and Pharmacodynamics of BI 1595043, a Selective Vanin Inhibitor, in Phase 1 Clinical Trials Involving Healthy Volunteers. [PDF]

Clin Transl Sci
Kukreja A, Keller S, Shatillo Y, Bauer A, Sharma A, Wojciekowski S, Visvanathan S, Aslanyan S.   +7 more
europepmc   +1 more source

Re‐Evaluation of Fixed Dosing Versus Body Size‐Based Dosing Approaches for Large Molecule Therapeutics in Adults

Clinical Pharmacology &Therapeutics, EarlyView.
Wang et al.1 (2009) and Zhang et al.2 (2011) recommended a fixed dosing approach for large molecule therapeutics for first‐in‐human (FIH) trials, based on the finding that the majority of α values (body size effect on clearance) were < 0.5 across 12 monoclonal antibodies (mAbs) and 18 therapeutic proteins (TPs) and peptides, and fixed dosing provides ...
Andrew B. SyBing, Huili Chen, Diane D. Wang   +2 more
wiley   +1 more source

Effectiveness and Safety of Reduced‐Dose Prasugrel in an East Asian Population: PRASFIT‐ACS Emulation Using National Health Insurance Claims Data

Clinical Pharmacology &Therapeutics, EarlyView.
Prasugrel is recommended for acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI). However, East Asians exhibit a stronger antiplatelet response, raising concerns about bleeding risks with standard dosing. This retrospective cohort study evaluated the real‐world effectiveness and safety of reduced‐dose prasugrel in
Li‐Wen Huang, Yee‐Jen Wu, Fang‐Ju Lin, Chien‐Chih Wu, Hsin‐Yi Huang, Chi‐Chuan Wang, Xiaojuan Li   +6 more
wiley   +1 more source

Population pharmacokinetics of mavacoxib after oral administration of a single dose to African grey parrots (Psittacus erithacus) [PDF]

, 2019
Antonissen, Gunther, Ardiaca, Maria, De Baere, Siegrid, Devreese, Mathias, Montesinos, Andres   +4 more
core   +1 more source

Safety, Pharmacokinetics, and Pharmacodynamics of Osivelotor for Sickle Cell Disease: First‐in‐Human Studies in Healthy Participants and Patients

Clinical Pharmacology &Therapeutics, EarlyView.
The investigational agent osivelotor, a small molecule hemoglobin (Hb) modifier in development for the treatment of sickle cell disease (SCD), acts by increasing Hb‐oxygen affinity and inhibiting the polymerization of sickle Hb. We report safety, pharmacokinetic (PK), and pharmacodynamic (PD) data from the first two phase 1 clinical trials of ...
Eleanor A. Lisbon, R. Clark Brown, Andrew Redfern, Ken Duchin, Aline Barth, Erika S. Roberts, Polo Gaputan, Kobina Dufu, Arthur Lo, Mira Patel Pochron, David R. Archer, Wai Chin, Karena Kong, Carla B. Washington, Adeyemi Adenola, Eric I. Zimmerman   +15 more
wiley   +1 more source

A randomized, double-blind, placebo-controlled, Phase 1 study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an immediate-release oral ketamine capsule in healthy volunteers. [PDF]

J Psychopharmacol
Qureshi M, Silman D, Gadelrab R, Stein HC, Carmellini P, Duncan G, Mehta MA, Young AH, Reilly C, Juruena MF.   +9 more
europepmc   +1 more source

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

Clinical Pharmacology &Therapeutics, EarlyView.
We present model‐informed selection of the recommended dose for expansion (RDE) of investigational oral ATR inhibitor tuvusertib, by integrating clinical pharmacokinetics (PK), pharmacodynamics (PD), and safety data from DDRiver Solid Tumors 301 trial Part A1 (NCT04170153).
Jatinder Kaur Mukker, Paul Matthias Diderichsen, Farina Hellmann, Timothy A. Yap, Ruth Plummer, Anthony W. Tolcher, Johann S. de Bono, Ioannis Gounaris, Zoltan Szucs, Astrid Zimmermann, Irina Kareva, Jayaprakasam Bolleddula, Annick Seithel‐Keuth, Giuseppe Locatelli, Marta Enderlin, Christine Hicking, Anup Zutshi, Wei Gao, Rainer Strotmann, Lisa Benincosa, Karthik Venkatakrishnan   +20 more
wiley   +1 more source

A phase I trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered low-anticoagulant heparin (M6229) in critically ill sepsis patients. [PDF]

Intensive Care Med Exp
van Mourik N, van Amstel RBE, Slim MA, van Vught LA, van der Poll T, Huckriede J, de Vries F, de Kimpe SJ, Crabbé R, van Leeuwen SJM, Ekhart PF, Reutelingsperger CPM, Nicolaes GAF, Vlaar APJ, Müller MCA.   +14 more
europepmc   +1 more source

Quantitative Model‐Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Clinical Pharmacology &Therapeutics, EarlyView.
Milvexian, an activated factor XI inhibitor, is being evaluated in the LIBREXIA phase III program for the prevention of thrombotic events, including in patients with atrial fibrillation (LIBREXIA AF). To guide the selection of a phase III dose regimen for LIBREXIA AF, two main approaches were used: (1) population pharmacokinetics and exposure–response ...
Wangda Zhou, Emily Bozenhardt, Gregory E. Alexander, Matthew L. Zierhut, Samira Merali, Antoinette Ajavon‐Hartmann, Peter Zannikos, Hyunmoon Back, EunYoung Suh, Navin Goyal, Mahesh N. Samtani, Alexei N. Plotnikov, Chandni Valiathan   +12 more
wiley   +1 more source