Results 31 to 40 of about 6,010 (176)

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

Pharmacometric estimation methods for aggregate data, including data simulated from other pharmacometric models [PDF]

Journal of Pharmacokinetics and Pharmacodynamics, 2021
AbstractLack of data is an obvious limitation to what can be modelled. However, aggregate data in the form of means and possibly (co)variances, as well as previously published pharmacometric models, are often available. Being able to use all available data is desirable, and therefore this paper will outline several methods for using aggregate data as ...
openaire   +2 more sources

Standards for model-based early bactericidal activity analysis and sample size determination in tuberculosis drug development

Frontiers in Pharmacology, 2023
Background: A critical step in tuberculosis (TB) drug development is the Phase 2a early bactericidal activity (EBA) study which informs if a new drug or treatment has short-term activity in humans.
Laurynas Mockeliunas, Alan Faraj, Rob C. van Wijk, Caryn M. Upton, Gerben van den Hoogen, Andreas H. Diacon, Ulrika S. H. Simonsson   +6 more
doaj   +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

Pharmacokinetic analysis of linezolid for multidrug resistant tuberculosis at a tertiary care centre in Mumbai, India

Frontiers in Pharmacology, 2023
Linezolid is an oxazolidinone used to treat multidrug-resistant tuberculosis (MDR-TB), including in the recently-endorsed shorter 6-month treatment regimens. Due to its narrow therapeutic index, linezolid is often either dose-adjusted or discontinued due
Juan Eduardo Resendiz-Galvan, Prerna R. Arora, Mahmoud Tareq Abdelwahab, Zarir F. Udwadia, Camilla Rodrigues, Amita Gupta, Amita Gupta, Amita Gupta, Paolo Denti, Tester F. Ashavaid, Jeffrey A. Tornheim, Jeffrey A. Tornheim, Jeffrey A. Tornheim   +12 more
doaj   +1 more source

Machine Learning and Pharmacometrics for Prediction of Pharmacokinetic Data: Differences, Similarities and Challenges Illustrated with Rifampicin

Pharmaceutics, 2022
Pharmacometrics (PM) and machine learning (ML) are both valuable for drug development to characterize pharmacokinetics (PK) and pharmacodynamics (PD). Pharmacokinetic/pharmacodynamic (PKPD) analysis using PM provides mechanistic insight into biological ...
Lina Keutzer, Huifang You, Ali Farnoud, Joakim Nyberg, Sebastian G. Wicha, Gareth Maher-Edwards, Georgios Vlasakakis, Gita Khalili Moghaddam, Elin M. Svensson, Michael P. Menden, Ulrika S. H. Simonsson, on behalf of the UNITE4TB Consortium   +11 more
doaj   +1 more source

Application of Physiologically‐Based and Population Pharmacokinetic Modeling for Dose Finding and Confirmation During the Pediatric Development of Moxifloxacin

CPT: Pharmacometrics & Systems Pharmacology, 2019
Moxifloxacin is a widely used fluoroquinolone for the treatment of complicated intra‐abdominal infections. We applied physiologically‐based pharmacokinetic (PBPK) and population pharmacokinetic (popPK) modeling to support dose selection in pediatric ...
Stefan Willmann, Matthias Frei, Gabriele Sutter, Katrin Coboeken, Thomas Wendl, Thomas Eissing, Jörg Lippert, Heino Stass   +7 more
doaj   +1 more source

Population pharmacokinetics of levofloxacin in breastmilk in patients with rifampicin‐resistant tuberculosis

British Journal of Clinical Pharmacology, EarlyView.
Levofloxacin is a widely used antibiotic included in rifampicin‐resistant tuberculosis (RR‐TB) treatment. Data describing levofloxacin concentrations in breastmilk and infant exposure are limited. We analysed data from two South African studies of breastfeeding women receiving levofloxacin (750–1000 mg daily) for RR‐TB.
Sharon Sawe, Lufina Tsirizani, Buyisile Mkhize, Lubbe Wiesner, Gary Maartens, Francesca Conradie, Richard Court, Marian Loveday, Catriona Waitt, Paolo Denti   +9 more
wiley   +1 more source

The Role of Pharmacometrics in Advancing the Therapies for Autoimmune Diseases

Pharmaceutics
Autoimmune diseases (AIDs) are a group of disorders in which the immune system attacks the body’s own tissues, leading to chronic inflammation and organ damage.
Artur Świerczek, Dominika Batko, Elżbieta Wyska   +2 more
doaj   +1 more source