Results 81 to 90 of about 11,033 (240)

Standard Error of Empirical Bayes Estimate in NONMEM® VI. [PDF]

, 2012
The pharmacokinetics/pharmacodynamics analysis software NONMEM® output provides model parameter estimates and associated standard errors. However, the standard error of empirical Bayes estimates of inter-subject variability is not available. A simple and
Bae, Kyun-Seop, Houk, Brett E, Kang, Dongwoo, Karlsson, Mats O, Savic, Radojka M   +4 more
core   +2 more sources

The Visual Predictive Check and Real‐World Data

Clinical Pharmacology &Therapeutics, EarlyView.
The visual predictive check (VPC) is a standard tool for assessing pharmacometric model suitability, producing visualizations that compare observed data with simulated data such that both model structure and model variability terms can be assessed. However, real‐world data commonly reflect clinical decision‐making that adapts therapy in response to ...
Jasmine H. Hughes, Martin Bergstrand, Ron J. Keizer   +2 more
wiley   +1 more source

Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis‐Associated Pain: An Application of Markov Model

CPT: Pharmacometrics & Systems Pharmacology, 2020
Elagolix is an oral gonadotropin‐releasing hormone antagonist approved by the US Food and Drug Administration (FDA) for the management of moderate‐to‐severe pain associated with endometriosis and in combination with estradiol/norethindrone acetate ...
Insa Winzenborg, Akshanth R. Polepally, Ahmed Nader, Nael M. Mostafa, Peter Noertersheuser, Juki Ng   +5 more
doaj   +1 more source

A Review of Virtual Twins in Physiologically‐Based Pharmacokinetic Modeling and Simulation

Clinical Pharmacology &Therapeutics, EarlyView.
The novel application of Virtual Twins (VT) in PBPK (VT‐PBPK) presents the opportunity to advance precision dosing and accelerate the shift from one‐size‐fits‐all to targeted, individualized treatments. This review aims to: (1) critically evaluate existing research on the use of VTs in PBPK, (2) develop a conceptual definition of VT‐PBPK, (3) describe ...
Emily Mannix, Sam Mostafa, Amin Rostami‐Hodjegan, Thomas M. Polasek, Carl M. J. Kirkpatrick   +4 more
wiley   +1 more source

Clinical pharmacology as a foundation for translational science. [PDF]

, 2011
The evolution of enabling technologies and their associated perspectives into molecular mechanisms underlying disease has extended beyond the abilities of scientific and clinical structures to advance their translation into new algorithms that improve ...
Hohl, R J., Kearns, G L., Swan, S J., Terzic, A, Waldman, Scott A.   +4 more
core   +2 more sources

Clinical Model‐Informed Precision Dosing Consult Service for Accelerating Personalized Medication in Pediatric Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Traditional dosing strategies often rely on a “one‐size‐fits‐all” paradigm, assuming an “average” patient with typical demographic and pharmacological characteristics. In reality, this often overlooks existing between‐patient variability and can lead to suboptimal drug exposure or toxicity. This issue is especially pronounced in pediatric patients, who
Zachary L. Taylor, Takanobu Nadai, Kei Irie, Wen Rui Tan, Sanjana Parikh, Anhar Hosawi, Matthijs W. van Hoogdalem, Ronaldo Morales Junior, Sonya Tang Girdwood, Abbie D. Leino, Kana Mizuno, Alexander A. Vinks, Tomoyuki Mizuno   +12 more
wiley   +1 more source

Multiscale classification of heart failure phenotypes by unsupervised clustering of unstructured electronic medical record data

Scientific Reports, 2020
As a leading cause of death and morbidity, heart failure (HF) is responsible for a large portion of healthcare and disability costs worldwide. Current approaches to define specific HF subpopulations may fail to account for the diversity of etiologies ...
Tasha Nagamine, Brian Gillette, Alexey Pakhomov, John Kahoun, Hannah Mayer, Rolf Burghaus, Jörg Lippert, Mayur Saxena   +7 more
doaj   +1 more source

Pharmacokinetic-Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance. [PDF]

, 2018
Pharmacokinetic/pharmacodynamic (PKPD) modeling is important in the design and conduct of clinical pharmacology research in children. During drug development, PKPD modeling and simulation should underpin rational trial design and facilitate extrapolation
A Cram, A Hooker, A Rao, AA Vinks, AH Thomson, AK Done, AM Johansson, AN Edginton, AN Edginton, AR Maharaj, AR Maharaj, B Green, B Quijano Ruiz, BJ Anderson, BJ Anderson, C Stockmann, CA Knibbe, CC Peck, CF Weiss, Charlotte I. S. Barker, CI Barker, CIS Barker, D Lin, DB Hawcutt, DJ Eleveld, E Germovsek, E Germovsek, E Germovsek, E Kimland, E Manolis, E Manolis, EI Ette, EI Ette, Eva Germovsek, F Rodieux, FG Benedict, G Langdon, G Nellis, GEP Box, GJ Robbie, GL Kearns, H Kimko, H Mulla, H Padari, H Shirkey, HG Eichler, HM Jones, HS Al-Sallami, I Adatia, I Bains, I Mahmood, I Mahmood, I Mahmood, IH Bartelink, J Alcorn, J Dunne, J Gillis, J Lerman, J Nyberg, J Nyberg, JA Roberts, JD Crawford, JE Sager, JF Standing, JF Standing, JF Standing, JK Roberts, JM Nicolas, Joseph F. Standing, JR Bellis, JS Barrett, JS Barrett, JS Barrett, JT Gilman, K Kipper, KD Wittmeier, KL Brouwer, L Aarons, L Cuzzolin, L Harnisch, L Harnisch, LE Kelly, LV Hampson, M Cella, M Cella, M Cella, M Danhof, M Jamei, M Kleiber, M Kleiber, M Minocha, M Neely, M Pfister, M Rowland, MA Montenegro, MA Turner, MA Turner, MA Turner, MA Turner, Mike Sharland, ML Christensen, MM Rhodin, MO Karlsson, MY Peeters, N Holford, N Kleiber, N Modi, NH Holford, P Espie, PA Valitalo, PD Joseph, PH Graaf van der, RE Kauffman, RF Cock De, RM Ward, RM Ward, RS Kadam, RW Jelliffe, S Conroy, S Duffull, S Feng, S Hennig, S Hennig, S Kanoh, S Leroux, SC McLeay, SE Tett, SG Wicha, SM MacLeod, SW Briggs, T Schechter, TA Leil, TA Leil, TH Nguyen, TN Johnson, TN Johnson, TN Johnson, TP Klassen, TS Samant, V Ramos-Martin, VH Tam, W Knebel, W Van’t Hoff, W Zhao, WA Silverman, Y Wang   +145 more
core   +2 more sources

AI‐Enabled Precision Dosing in Pediatrics: Enhancing Model‐Informed Decision Making

Clinical Pharmacology &Therapeutics, EarlyView.
Ensuring safe and effective pharmacotherapy for children remains a central challenge in clinical pharmacology, yet rapid advances in AI have not translated into clinical practice. This Perspective highlights how AI‐enabled approaches can enhance model‐informed decision making for precision dosing.
Kei Irie, Tomoyuki Mizuno
wiley   +1 more source

Design and conduct of early phase drug studies in children: challenges and opportunities [PDF]

, 2016
It has historically been very difficult to conduct early phase drug studies in children for a number of reasons related to ethics, acceptability, rarity, standardization, end points, safety, dosing and feasibility.
Hawcutt, Daniel, Rieder, Michael
core   +2 more sources