Results 11 to 20 of about 690 (120)

An Open‐Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design [PDF]

CPT: Pharmacometrics & Systems Pharmacology
To establish bioequivalence (BE) of a generic test formulation with respect to a reference listed drug, it is necessary to demonstrate a comparable rate and extent to which active ingredients reach the site of action.
Abdullah Hamadeh, Moriah Pellowe, Pierre Chelle, Cindy Hoi Ting Yeung, Julian Otalvaro, Walter Yamada, Jay Bartroff, Alona Kryshchenko, André Dallmann, Juri Solodenko, Jörg Lippert, Eleftheria Tsakalozou, Michael Neely, Andrea Edginton   +13 more
doaj   +4 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
exaly   +5 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

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, Siri Kalyan Chirumamilla, Frédéric Y Bois   +2 more
exaly   +3 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

Efficacy, Safety and PK of Once-Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model-Informed Drug Development Approach. [PDF]

Diabetes Obes Metab
ABSTRACT Aims Semaglutide has previously been approved for weight management and cardiovascular disease as a subcutaneous formulation, and more recently also as an oral formulation. However, there is limited information across oral dose levels, and there are no studies for the 25 mg dose in people with obesity and type 2 diabetes (T2D).
Overgaard RV, Birkhan O, Rathor N, Sparsø T, Strathe A, Wharton S, Rubino D.   +6 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

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

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