Results 21 to 30 of about 4,403,980 (152)

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

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

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

Model Master File Framework: A Regulatory Path Advancing Modeling and Simulation Applications. [PDF]

Clin Transl Sci
ABSTRACT To advance drug product development, regulatory decision making, and improve patient care, FDA has committed to the quantitative medicine paradigm that involves, among others, quantitative in silico methodologies and tools developed based on nonclinical, clinical, and real‐world sources. In this Perspective, Model Master File (MMF) submissions
Tsakalozou E, Erdman R, Zhang L, Lionberger R, Fang L.   +4 more
europepmc   +2 more sources

Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic cornerstone of model‐informed drug development (MIDD), providing evidence for regulatory decisions. PBPK models integrate physiological and pharmacological data and have been applied across a plethora of contexts of use, including assessing drug–drug interactions (DDIs ...
Chenel M, Dallmann A, Ince I, Meyer M, Schlender JF, Teutonico D, Sjögren E.   +6 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

A Review of Virtual Twins in Physiologically-Based Pharmacokinetic Modeling and Simulation. [PDF]

Clin Pharmacol Ther
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 ...
Mannix E, Mostafa S, Rostami-Hodjegan A, Polasek TM, Kirkpatrick CMJ.   +4 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

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

Machine Learning Enables Rapid Prediction of Acid-Reducing Agent Drug Interactions: A Streamlined Complement to PBPK Modeling. [PDF]

CPT Pharmacometrics Syst Pharmacol
Machine Learning Enables Rapid Prediction of Acid‐Reducing Agent Drug Interactions: A Streamlined Complement to PBPK Modeling. ABSTRACT pH‐dependent drug–drug interactions (DDIs) commonly occur when acid‐reducing agents (ARAs) are co‐administered with weakly basic drugs.
Qin Y, Yu L, Chen T, Zuo Y, Wang H, Yang G, Pei Q.   +6 more
europepmc   +2 more sources