Results 31 to 40 of about 11,033 (240)

Translational Pharmacometric Evaluation of Typical Antibiotic Broad-Spectrum Combination Therapies Against Staphylococcus Aureus Exploiting In Vitro Information [PDF]

, 2017
Broad-spectrum antibiotic combination therapy is frequently applied due to increasing resistance development of infective pathogens. The objective of the present study was to evaluate two common empiric broad-spectrum combination therapies consisting of ...
Huisinga, Wilhelm, Kloft, Charlotte, Wicha, Sebastian G.   +2 more
core   +1 more source

Commentary on Pharmacometrics for Immunotherapy.

CPT: pharmacometrics & systems pharmacology, 2017
This commentary provides an overview of recent examples of pharmacometrics applied during the clinical development of two antagonists of the programmed death-1 (PD-1) cell surface receptor, pembrolizumab and nivolumab. Despite the remarkable achievements obtained in predicting the correct dosing schedule from different quantitative approaches, data ...
Garrido, MJ, Berraondo, P, Trocóniz, IF
openaire   +3 more sources

Systems Toxicology Approach to Identifying Paracetamol Overdose [PDF]

, 2018
Paracetamol (acetaminophen (APAP)) is one of the most commonly used analgesics in the United Kingdom and the United States. However, exceeding the maximum recommended dose can cause serious liver injury and even death.
Ambrosius, Antoine, Antoine, Antoine, Antoine, Antoine, Bateman, Bateman, Bechmann, Beger, Ben-Shachar, Bewick, Brillant, Chiew, Clarke, Coen, Dear, Diaz Ochoa, Giannini, Hinson, Jaeschke, Juurlink, Larson, Lea, Longo, Maaten, Metzler, Reddyhoff, Reith, Remien, Remien, Rumack, Sharma, Shoda, Williams   +34 more
core   +4 more sources

Optimization of trial duration to predict long‐term HbA1c change with therapy: A pharmacometrics simulation‐based evaluation

CPT: Pharmacometrics & Systems Pharmacology, 2022
Glycated hemoglobin (HbA1c) is the main biomarker of diabetes drug development. However, because of its delayed turnover, trial duration is rarely shorter than 12 weeks, and being able to predict long‐term HbA1c with precision using data from shorter ...
Hanna Kunina, Alex Al‐Mashat, Jenny Y. Chien, Parag Garhyan, Maria C. Kjellsson   +4 more
doaj   +1 more source

Exposure‐Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis‐Associated Pain

CPT: Pharmacometrics & Systems Pharmacology, 2020
Elagolix is a novel oral gonadotropin releasing hormone receptor antagonist, that can suppress estradiol in a dose‐dependent manner. It is indicated for management of moderate‐to‐severe pain associated with endometriosis.
Ahmed Abbas Suleiman, Ahmed Nader, Insa Winzenborg, Denise Beck, Akshanth R. Polepally, Juki Ng, Peter Noertersheuser, Nael M. Mostafa   +7 more
doaj   +1 more source

Pharmacokinetic Models to Characterize the Absorption Phase and the Influence of a Proton Pump Inhibitor on the Overall Exposure of Dacomitinib

Pharmaceutics, 2020
Introduction: Dacomitinib is an epidermal growth factor receptor (EGFR) inhibitor approved for the treatment of metastatic non-small cell lung cancer (NSCLC) in the first line in patients with EGFR activating mutations.
Ana Ruiz-Garcia, Weiwei Tan, Jerry Li, May Haughey, Joanna Masters, Jennifer Hibma, Swan Lin   +6 more
doaj   +1 more source

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014) [PDF]

, 2017
Inadequate dose selection for confirmatory trials is currently still one of the most challenging issues in drug development, as illustrated by high rates of late-stage attritions in clinical development and postmarketing commitments required by ...
Benda, N, Berry, S, Bornkamp, B, Bretz, F, Brochot, A, Cheung, S, Cole, S, Corriol-Rohou, S, Das, S, Dumortier, T, Ehmann, F, Friberg, LE, Gigante, V, Hay, J, Hemmings, R, Holford, N, Hooker, AC, Karlsson, K, Manolis, E, Musuamba, FT, Ogungbenro, K, Posch, M, Rusten, IS, Serone, F, Standing, JF, Thomas, N, Van der Graaf, PH, Yates, J   +27 more
core   +1 more source

Pharmacometric Characterization of Dabigatran Hemodialysis [PDF]

Clinical Pharmacokinetics, 2013
Hemodialysis has been shown to be a useful method of decreasing dabigatran plasma levels in situations that require rapid elimination of this thrombin inhibitor. However, there is currently no clinical recommendation for the accelerated/optimized elimination of dabigatran via hemodialysis (e.g., flow rates, filter type, duration of dialysis).The ...
Liesenfeld, Karl-Heinz, Staab, Alexander, Härtter, Sebastian, Formella, Stephan, Clemens, Andreas, Lehr, Thorsten   +5 more
openaire   +2 more sources

Unraveling the Pharmacokinetic Interaction of Ticagrelor and MEDI2452 (Ticagrelor Antidote) by Mathematical Modeling [PDF]

, 2016
The investigational ticagrelor-neutralizing antibody fragment, MEDI2452, is developed to rapidly and specifically reverse the antiplatelet effects of ticagrelor.
Almquist, Joachim, Gennemark, P., Goodman, J., Janefeldt, A., Madalli, S., Maqbool, S., Nylander, S., Pehrsson, S., Penney, M., Sandinge, A-S   +9 more
core   +1 more source

Population pharmacokinetics and exposure‐response modeling analyses of guselkumab in patients with psoriatic arthritis

Clinical and Translational Science, 2022
Guselkumab is an anti‐interleukin‐23 human monoclonal antibody effective in treating psoriatic arthritis (PsA). To characterize the pharmacokinetics (PKs) and exposure‐response relationship of guselkumab in PsA, population PKs, and exposure‐response ...
Yang Chen, Xin Miao, Chyi‐Hung Hsu, Yanli Zhuang, Alexa Kollmeier, Zhenhua Xu, Honghui Zhou, Amarnath Sharma   +7 more
doaj   +1 more source