Results 51 to 60 of about 1,942 (154)

Formulation development, in vivo bioequivalence and pediatric PBPK modeling studies of taste-masked ciprofloxacin chewable tablets

Scientific Reports, 2023
A taste-masked chewable tablet of ciprofloxacin using ion exchange resin Kyron T-134 for enhancing compliance for the paediatric population was developed.
Muhammad Talha Usmani, Muhammad Harris Shoaib, Fahad Siddiqui, Farrukh Rafiq Ahmed, Rabia Ismail Yousuf, Muhammad Talha Saleem   +5 more
doaj   +1 more source

On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet

Pharmaceutics, 2021
The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro ...
Varun Kushwah, Sumit Arora, Miklós Tamás Katona, Dattatray Modhave, Eleonore Fröhlich, Amrit Paudel   +5 more
doaj   +1 more source

In Vitro–In Vivo Correlation (IVIVC) Population Modeling for the In Silico Bioequivalence of a Long-Acting Release Formulation of Progesterone

Pharmaceutics, 2021
Health authorities carefully evaluate any change in the batch manufacturing process of a drug before and after regulatory approval. In the absence of an adequate in vitro–in vivo correlation (Level A IVIVC), an in vivo bioequivalence (BE) study is ...
Elena M. Tosca, Maurizio Rocchetti, Elena Pérez, Conchi Nieto, Paolo Bettica, Jaime Moscoso del Prado, Paolo Magni, Giuseppe De Nicolao   +7 more
doaj   +1 more source

Bioequivalence of alternative pembrolizumab dosing regimens: current practice and future perspectives. [PDF]

Cancer Commun (Lond)
Malmberg R, Agema BC, Hofman MM, Oosterveld S, Bins S, Dumoulin DW, Joosse A, Aerts JGJV, Debets R, Koch BCP, van der Veldt AAM, van Leeuwen RWF, Mathijssen RHJ.   +12 more
europepmc   +3 more sources

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
doaj   +1 more source

Is a Clinical Trial With a Non‐Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK

Clinical Pharmacology &Therapeutics, EarlyView.
Although physiologically based pharmacokinetic (PBPK) modeling is increasingly being used to support oral drug formulation bridging, the acceptance by regulatory agencies is low. One of the primary concerns is the absence of clinical pharmacokinetic (PK) data from a non‐bioequivalent (non‐BE) batch during model validation.
Jin Dong, Andrea Moir, Xavier Pepin, Elizabeth Lowe, Sandy Hopkins, Weifeng Tang, Diansong Zhou   +6 more
wiley   +1 more source

Applications of simulation within the healthcare context [PDF]

, 2011
This is a pre-print of an article published in Journal of the Operation Research Society. The definitive publisher-authenticated version Katsaliaki, K., Mustafee, N.,(2010). Applications of simulation within the healthcare context.
Amoako-Gympah K, Dexter F, England W, Hay JW, K Katsaliaki, Murphy KM, N Mustafee, Pannirselvam GP, Pidd M, Robinson S, Rubinstein RY, Taylor K   +11 more
core   +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

Intranasal diamorphine population pharmacokinetics modeling and simulation in pediatric breakthrough pain

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 435-447, March 2025.
Abstract Intranasal diamorphine (IND), approved for managing breakthrough pain in the UK, has been identified as an acceptable alternative offering effective, expedient, and less traumatic analgesia for children. However, the current dose regimen in pediatric populations relies on clinical expertise while the pharmacokinetics properties are poorly ...
Lianjin Cai, Jingchen Zhai, Beihong Ji, Fengyang Han, Taoyu Niu, Luxuan Wang, Junmei Wang   +6 more
wiley   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source