Results 21 to 30 of about 1,942 (154)

Numerical Verification of Tucuxi, a Promising Bayesian Adaptation Tool for Model‐Informed Precision Dosing [PDF]

CPT: Pharmacometrics & Systems Pharmacology
Tucuxi, a Swiss‐developed Model‐Informed Precision Dosing (MIPD) software, aims to support clinical dosage decision‐making to achieve therapeutic concentration targets.
Anne Ravix, Annie E. Cathignol, Thierry Buclin, Chantal Csajka, Monia Guidi, Yann Thoma   +5 more
doaj   +2 more sources

Physiologically Based Pharmacokinetic Virtual Twin Approach for Fludarabine Dosing in Pediatric Hematopoietic Stem Cell Transplantation. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Fludarabine (Flu), administered as a prodrug Flu monophosphate, is a lymphodepleting agent used prior to hematopoietic stem cell transplantation (HSCT) which exhibits substantial pharmacokinetics (PK) variability, contributing to suboptimal outcomes.
Mseddi M, Nath C, Ben Hassine K, Mlakar V, Gloor Y, Gonzales F, Uppugunduri CRS, Daali Y, Keogh S, Ansari M.   +9 more
europepmc   +2 more sources

Conjunction of semi-mechanistic in vitro-in vivo modeling and population pharmacokinetics as a tool for virtual bioequivalence analysis - a case study for a BCS class II drug

European Journal of Pharmaceutics and Biopharmaceutics, 2023
Virtual bioequivalence trial (VBE) simulations based on (semi)mechanistic in vitro-in vivo (IVIV) modeling have gained a huge interest in the pharmaceutical industry. Sophisticated commercially available software allows modeling variable drug fates in the gastrointestinal tract (GIT).
Dorota Danielak, Jadwiga Paszkowska, Marcela Staniszewska, Grzegorz Garbacz, Anna Terlecka, Bartłomiej Kubiak, Michał Romański   +6 more
openaire   +4 more sources

Validating Physiologically-Based Pharmacokinetic Models Using the Continuous Ranked Probability Score: Beyond Being Correct on Average. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Physiologically‐based pharmacokinetic (PBPK) models have become increasingly popular for model‐informed drug development (MIDD) over the past decade. While several guidelines for model evaluation exist, these are by design often of a general and non‐specific nature. It is clear what steps should be carried out but not necessarily how.
Sluijterman L, van Borselen M, Greupink R, IntHout J.   +3 more
europepmc   +2 more sources

Using the Simcyp R Package for PBPK Simulation Workflows With the Simcyp Simulator [PDF]

CPT: Pharmacometrics & Systems Pharmacology
Physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling aims to understand how a drug is absorbed, distributed, metabolized, excreted, and acts in a human or animal body.
Anthonia M. Onasanwo, Naresh Mittapelly, Laura Shireman, Barry Vinden, Kevin McNally, James Craig, Frederic Y. Bois   +6 more
doaj   +2 more sources

Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations [PDF]

Clinical and Translational Science
The equivalence of absorption rates and extents between generic drugs and their reference formulations is crucial for ensuring therapeutic comparability.
Ting Luo, Lu Wang, Zourong Ruan, Honggang Lou, Dandan Yang, Zhiyang Wang, Pengfei Zhao, Bo Jiang   +7 more
doaj   +2 more sources

A QSP Model of Valproic Acid Toxicity in Pediatric and Adult Populations: Implications for Formulation Selection and L-Carnitine Supplementation. [PDF]

CPT Pharmacometrics Syst Pharmacol
Schematic workflow of the QSP model development and application. The study builds upon an initial adult male model structure (top left) by integrating reported data on age‐related changes in elimination pathways (top right). This allowed for the extension of the QSP model to pediatric and female populations (bottom right), which was then used to ...
Schiavo A, Maldonado C, Vázquez M, Fagiolino P, Trocóniz IF, Ibarra M.   +5 more
europepmc   +2 more sources

Managing Delayed or Missed Doses of Prolonged-Release Tacrolimus in Transplant Recipients: Implications for Drug Exposure and Recovery Strategies. [PDF]

Basic Clin Pharmacol Toxicol
This simulation–based analysis quantified the impact of delayed and missed doses of prolonged–release tacrolimus in kidney and liver transplant recipients. A single missed dose reduced AUC24h by up to 50% and required 2–4 days to return to steady state.
Arraki Zava S, Maizaud F, Sayadi H, Fromage Y, Marquet P, Woillard JB, Monchaud C.   +6 more
europepmc   +2 more sources

Application in silico Modeling Simulation in Bioequivalence Studies: A Review

Journal of Food and Pharmaceutical Sciences, 2023
Bioequivalence testing aims to ensure that the therapeutic performance of the drug is consistent and reproducible when it is administrated. Modeling and simulation in silico methods are currently performed to conduct virtual bioequivalence studies ...
Sekar Ayu Pawestri
doaj   +1 more source

VIRTUAL BIOEQUIVALENCE IN PHARMACEUTICALS: CURRENT STATUS AND FUTURE PROSPECTS

International Journal of Applied Pharmaceutics, 2023
Virtual bioequivalence studies (VBE) can assess the similarity and potential differences in pharmacokinetic and clinical performance between test and reference formulations based on the translational relationship between in vitro, in silico, and in vivo.
SOWMYA C., ABRAR AHMED H., SURIYA PRAKAASH K. K.   +2 more
openaire   +1 more source