Results 81 to 90 of about 6,245 (194)

Advances in Human Mass Balance Studies: An IQ Consortium Perspective on Current Practices and Emerging Trends

Clinical Pharmacology &Therapeutics, Volume 120, Issue 1, Page 43-54, July 2026.
Human radiolabeled mass balance studies are crucial for comprehensively characterizing the absorption, distribution, metabolism, and excretion (ADME) of investigational drugs, providing essential data for drug development, regulatory evaluation, and product labeling.
Jason Boer, Ellen Cannady, Filip Cuyckens, Ulrike Glaenzel, Camille Granvil, Felix Huth, Alexander D. James, Wenying Li, Céline Veau, Graeme Young, Qin Yue, Gregory S. Walker, Upendra A. Argikar, Jonathan N. Bauman, Cathy Cantalloube, Yu‐Luan Chen, Ping Kang, Patricia Moliner, Mette L. Pedersen, Isabel Piel, Simone Schadt, Hanno Schieferstein, Julia Suchomel, Shuai Wang, S. Cyrus Khojasteh   +24 more
wiley   +1 more source

Integrating Population Approaches With Physiologically Based Pharmacokinetic Models: A Novel Framework for Parameter Estimation

CPT: Pharmacometrics & Systems Pharmacology
Physiologically Based Pharmacokinetic (PBPK) modeling is a powerful tool in drug development that integrates drug‐specific information with physiological parameters to predict drug concentrations.
Donato Teutonico, David Marchionni, Marc Lavielle, Laurent Nguyen   +3 more
doaj   +1 more source

Getting It Right the Second Time: How Can we Optimize First‐Generation Cephalosporin Dosing for Skin and Soft Tissue Infections in the 21st Century?

Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, Volume 46, Issue 7, July 2026.
ABSTRACT Optimal cephalexin and cefadroxil dosing for skin and soft tissue infections (SSTIs) is unclear. We summarize clinical and pharmacokinetic/pharmacodynamic (PK/PD) data that compare dosing strategies for SSTIs. Additionally, we conduct population PK target attainment simulations for varying doses of cephalexin and cefadroxil for Staphylococcus ...
Jonathan H. Ryder, Shawnalyn W. Sunagawa, Nathaniel J. Rhodes, Trevor C. Van Schooneveld, Jeremy E. Tigh, Sean N. Avedissian, Nicolas Cortes‐Penfield   +6 more
wiley   +1 more source

Covariate modeling in pharmacometrics: General points for consideration

CPT: Pharmacometrics & Systems Pharmacology
Modeling the relationships between covariates and pharmacometric model parameters is a central feature of pharmacometric analyses. The information obtained from covariate modeling may be used for dose selection, dose individualization, or the planning of
Kinjal Sanghavi, Jakob Ribbing, James A. Rogers, Mariam A. Ahmed, Mats O. Karlsson, Nick Holford, Estelle Chasseloup, Malidi Ahamadi, Kenneth G. Kowalski, Susan Cole, Essam Kerwash, Janet R. Wade, Chao Liu, Yaning Wang, Mirjam N. Trame, Hao Zhu, Justin J. Wilkins, for the ISoP Standards & Best Practices Committee   +17 more
doaj   +1 more source

A Combined Modeling Approach to Predict the Effect of Gastric Emptying Delay on the Pharmacokinetics of Small Molecules

CPT: Pharmacometrics & Systems Pharmacology
Dulaglutide, a long‐acting glucagon‐like peptide‐1 (GLP‐1) receptor agonist, is approved for improving glycemic control and reducing cardiovascular risks in patients with type 2 diabetes mellitus (T2DM).
Maria M. Posada, Karen B. Schneck, Bridget L. Morse, Luc R. A. Rougee, Lai San Tham, Jessica F. Rehmel, Brian Thompson, Stephen D. Stamatis, Stephen D. Hall, Gemma L. Dickinson   +9 more
doaj   +1 more source

Integrated Population Pharmacokinetic Analysis of Intravitreal Aflibercept Drug Products

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 7, July 2026.
ABSTRACT Neovascular age‐related macular degeneration (nAMD) and diabetic macular edema (DME) can cause substantial vision loss. The 2‐mg drug product of aflibercept (AFL‐2)—an anti‐vascular endothelial growth factor agent—has established efficacy and safety in both diseases.
Sébastien Bihorel, Joannellyn Chiu, Jason Chittenden, Thomas Eissing, Kenneth C. Turner, Joachim Höchel, Torsten Zimmermann, Zhongqing Will He, John D. Davis, A. Thomas DiCioccio, Lutz O. Harnisch   +10 more
wiley   +1 more source

Butorphanol Pharmacokinetics Across Species: Meta‐Analysis Integrating Allometric Scaling and Minimal Physiologically Based Pharmacokinetic Modeling

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 7, July 2026.
mPBPK Allometric Meta‐Analysis (MAMA) of Butorphanol Across 13 Species. ABSTRACT Butorphanol, an opioid agonist–antagonist used in human and veterinary medicine, lacks systematic interspecies comparisons. Butorphanol pharmacokinetics (PK) was assessed across species using a minimal physiologically based PK (mPBPK) model and allometric scaling, termed ...
Ahmed M. Saeed, William J. Jusko
wiley   +1 more source

Model‐Informed Development of a Subcutaneous Formulation of Tislelizumab: Phase 1 Pharmacokinetics in Patients With Cancer

Clinical and Translational Science, Volume 19, Issue 7, July 2026.
ABSTRACT Although tislelizumab is approved across multiple malignancies and dosing schedules, intravenous administration imposes logistical burdens. A subcutaneous formulation may improve convenience and reduce resource demands if comparable exposure is achieved. This study evaluated the pharmacokinetics, bioavailability, and injection‐site performance
Xiangyu Liu, Ye Guan, Yixi Liu, Tian Yu, Ramil Abdrashitov, Ziru Niu, Xiao Lin, Xiaohan Ye, Yutong Wang, Srikumar Sahasranaman, William D. Hanley, Nageshwar Budha   +11 more
wiley   +1 more source

Efficacy, Safety and PK of Once‐Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model‐Informed Drug Development Approach

Diabetes, Obesity and Metabolism, Volume 28, Issue 7, Page 5982-5991, July 2026.
ABSTRACT Aims Semaglutide has previously been approved for weight management and cardiovascular disease as a subcutaneous formulation, and more recently also as an oral formulation. However, there is limited information across oral dose levels, and there are no studies for the 25 mg dose in people with obesity and type 2 diabetes (T2D).
Rune Viig Overgaard, Oscar Birkhan, Naveen Rathor, Thomas Sparsø, Anders Strathe, Sean Wharton, Domenica Rubino   +6 more
wiley   +1 more source

Population pharmacokinetics and pharmacodynamics of nasal glucagon in patients with type 1 or 2 diabetes

CPT: Pharmacometrics & Systems Pharmacology
The objective was to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of glucagon after injectable or nasal administration and confirm the appropriate therapeutic dose of nasal glucagon (NG) for adult patients.
Douglas E. James, Tong Shen, Jeanne S. Geiser, Parag Garhyan, Emmanuel Chigutsa   +4 more
doaj   +1 more source