Results 11 to 20 of about 1,942 (154)

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen [PDF]

European Journal of Pharmaceutical Sciences, 2020
Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set clinically relevant specifications.
Loisios-Konstantinidis, Ioannis, Cristofoletti, Rodrigo, Fotaki, Nikoletta, Turner, David B., Dressman, Jennifer   +4 more
core   +10 more sources

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria [PDF]

European Journal of Pharmaceutical Sciences, 2017
Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than the other for instance in achlorhydric patients where elevated gastric pH may lead to differential effects on ...
Doki, Kosuke; Darwich, Adam S.; Patel, Nikunjkumar; Rostami-Hodjegan, Amin   +4 more
core   +5 more sources

Virtual population pharmacokinetic using physiologically based pharmacokinetic model for evaluating bioequivalence of oral lacidipine formulations in dogs

Asian Journal of Pharmaceutical Sciences, 2017
The aim of the present study was to investigate virtual population pharmacokinetic using physiologically based pharmacokinetic (PBPK) model for evaluating bioequivalence of oral lacidipine formulations in dogs.
Bin Yang, Chunnuan Wu, Bin Ji, Mingrui Wu, Zhonggui He, Lei Shang, Jin Sun   +6 more
doaj   +5 more sources

Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption [PDF]

Journal of Pharmaceutical Sciences, 2022
A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor. Ribociclib is a weak base with moderate permeability and complete in vitro dissolution under stomach pH. GastroPlus™ was used to simulate the pharmacokinetics (PK) in healthy volunteers
Marc Laisney, Tycho Heimbach, Martin Mueller-Zsigmondy, Lars Blumenstein, Rui Costa, Yan Ji   +5 more
openaire   +4 more sources

Understanding Discordance between In Vitro Dissolution, Local Gut and Systemic Bioequivalence of Budesonide in Healthy and Crohn’s Disease Patients through PBPK Modeling [PDF]

Pharmaceutics, 2023
The most common method for establishing bioequivalence (BE) is to demonstrate similarity of concentration–time profiles in the systemic circulation, as a surrogate to the site of action.
Chunyan Han, Tiancheng Sun, Siri Kalyan Chirumamilla, Frederic Y. Bois, Mandy Xu, Amin Rostami-Hodjegan   +5 more
doaj   +2 more sources

DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet [PDF]

Pharmaceuticals
Background/Objectives: This study explores the integration of Design of Experiments (DoE) with Physiologically Based Biopharmaceutics Modeling (PBBM) to streamline the development of extended-release (XR) formulations.
Frederico Severino Martins, Leonardo Luiz Borges, Sivacharan Kollipara, Praveen Sivadasu, Renê Oliveira do Couto   +4 more
doaj   +2 more sources

Open Systems Pharmacology Community Conference (OSP-CC) Proceedings 2025. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Developed at Bayer Technology Services, PK‐Sim and MoBi transitioned into the Open Systems Pharmacology (OSP) Suite, released as free open‐source software in 2017. An active community with stakeholders from academia, industries, and regulators contributes to the continuous improvement of open‐source model‐informed drug development (MIDD). This
Cordes H, Annaert P, Balazki P, Benamara S, Bonan RH, Butler A, Chenel M, Cui Y, Dallmann A, de Witte WEA, Demeester C, Feick D, Gattacceca F, Geci R, Gerebtzoff G, Gruber A, Guimarães M, Hamadeh A, Hanke N, Ibarra M, Ince I, Kanacher T, Kuepfer L, Mil F, Montaseri G, Nauwelaerts N, Proenca S, Schaller S, Schlender JF, Schneider ARP, Sjögren E, Solodenko J, Staab A, Vrenken P, Troisi C, Teutonico D.   +35 more
europepmc   +2 more sources

Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference. [PDF]

Clin Pharmacol Ther
Pharmacometrics (PMX) in Africa has transitioned from foundational capacity‐building to job creation, scientific leadership, regulatory influence, and health innovation. To accelerate this progress, the 2025 Pharmacometrics Africa Conference (PMXAC‐2025) convened key stakeholders to consolidate the continental PMX community, review progress in local ...
Adeagbo BA, Asiimwe IG, Chaba L, Kawuma AN, Ojara FW, Orherhe OM, Asiimwe SP, Pillay-Fuentes Lorente V, Sawe S, Phogole CM, Waitt C, Mouksassi S, Pillai GC.   +12 more
europepmc   +2 more sources

Model-Informed Dosing Regimen of Sugemalimab for European Patients With Non-Small Cell Lung Cancer: Bridging From Asian Clinical Data. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Model‐informed drug development (MIDD) framework was employed to bridge sugemalimab dosing from an Asian population to European patients with non‐small cell lung cancer. We evaluated whether a fixed dose of 1200 mg every 3 weeks (Q3W) provides adequate exposure for European patients and, if not, which weight threshold and alternative dose ...
Sheng Y, Yue Z, Xu F, Wang K, Wang J, Shi Q.   +5 more
europepmc   +2 more sources

Introducing an Artificial Neural Network for Virtually Increasing the Sample Size of Bioequivalence Studies

Applied Sciences
Sample size is a key factor in bioequivalence and clinical trials. An appropriately large sample is necessary to gain valuable insights into a designated population.
Dimitris Papadopoulos, Vangelis D. Karalis   +1 more
doaj   +2 more sources