Results 71 to 80 of about 11,033 (240)

Proposed best practice for projects that involve modelling and simulation [PDF]

, 2017
Modelling and simulation has been used in many ways when developing new treatments. To be useful and credible, it is generally agreed that modelling and simulation should be undertaken according to some kind of best practice.
Anisimov, Burman, Burton, Cook, European Medicines Agency, Gaydos, Hemmings, Marshall, Smith   +8 more
core   +1 more source

Quantitative prediction of intravenous drug interactions caused by cytochromes P450 inhibitors and inducers

British Journal of Clinical Pharmacology, EarlyView.
Background Aims Pharmacokinetic interaction studies typically focus on oral administration, but intravenous (IV) administration bypasses intestinal degradation and hepatic first‐pass metabolism, leading to distinct drug–drug interaction (DDI) magnitude. This study aimed to develop a predictive model for DDIs involving IV‐administered drugs.
Vianney Tuloup, Michel Tod, Laurent Bourguignon   +2 more
wiley   +1 more source

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

Prediction of Response to Temozolomide in Low-Grade Glioma Patients Based on Tumor Size Dynamics and Genetic Characteristics [PDF]

, 2015
International audienceBoth molecular profiling of tumors and longitudinal tumor size data modeling are relevant strategies to predict cancer patients' response to treatment.
Alentorn, A, Barthélémy, Célia, Delattre, J-Y, Ducray, F, Honnorat, J, Idbaih, A, Kaloshi, G, Lavielle, Marc, Mazzocco, P, Psimaras, D, Renard, M-A, Ribba, B, Ricard, D   +12 more
core   +3 more sources

Physiologically‐based pharmacokinetic modelling of uridine 5′‐diphosphoglucorosultransferase (UGT) substrate drugs in pregnant women

British Journal of Clinical Pharmacology, EarlyView.
Aims While pregnancy‐related changes in phase I enzyme activity are well‐documented, less is known about the impact on phase II enzymes. This study aimed to test the hypothesis that changes in the pharmacokinetics (PK) of uridine 5′‐diphosphoglucuronosyltransferase (UGT) substrates during pregnancy result from altered enzyme expression or activity ...
William Saffaf, Ymke van der Velde, Paul R. V. Malik, Jelmer R. Prins, Sanne J. Gordijn, Daan J. Touw, Paola Mian   +6 more
wiley   +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

Combined Analysis of Phase I and Phase II Data to Enhance the Power of Pharmacogenetic Tests [PDF]

, 2016
International audienceWe show through a simulation study how the joint analysis of data from phase I and phase II studies enhances the power of pharmacogenetic tests in pharmacokinetic (PK) studies.
Bertrand, Julie, Chenel, Marylore, Comets, Emmanuelle, Tessier, Adrien   +3 more
core   +3 more sources

A dose‐finding population pharmacokinetic/pharmacodynamic model of ginisortamab, an anti‐gremlin‐1 monoclonal antibody, in patients with solid tumours

British Journal of Clinical Pharmacology, EarlyView.
Aims Ginisortamab, a first‐in‐class human monoclonal antibody for the treatment of advanced solid tumours, binds to gremlin‐1 and restores bone morphogenetic protein signalling. We used pharmacokinetic/pharmacodynamic (PK/PD) modelling to characterize the relationship between ginisortamab dose and serum gremlin‐1 binding, using model‐based simulations ...
Yin Cheong Wong, Luisa Rojas Chavarro, Paul Jones, David Egging, Wanchana Ungphakorn, Marta Valle, Ivan Matthews   +6 more
wiley   +1 more source

Translation of Anticancer Efficacy From Nonclinical Models to the Clinic [PDF]

, 2014
Mouse cancer models have provided critical insights into tumor biology; however, clinical translation of these findings has been challenging. This perspective posits that factors impacting on successful translation start with limitations in capturing ...
Duda, D G, Stroh, M, Takimoto, C H, Vicini, P, Yamazaki, S   +4 more
core   +1 more source

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

Clinical Pharmacology &Therapeutics, EarlyView.
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