Virtual population pharmacokinetic using physiologically based pharmacokinetic model for evaluating bioequivalence of oral lacidipine formulations in dogs [PDF]
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 +6 more
doaj +6 more sources
A Bayesian framework for virtual comparative trials and bioequivalence assessments [PDF]
Frontiers in PharmacologyIntroductionIn virtual bioequivalence (VBE) assessments, pharmacokinetic models informed with in vitro data and verified with small clinical trials’ data are used to simulate otherwise unfeasibly large trials.
Frederic Y. Bois, Céline Brochot
doaj +6 more sources
An Open‐Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design [PDF]
CPT: Pharmacometrics & Systems PharmacologyTo 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 +13 more
doaj +4 more sources
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.
K. K., SURIYA PRAKAASH +2 more
core +3 more sources
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling [PDF]
AAPS Journal, 2022 AbstractWhile the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on VBE outcomes requires demonstration of its ability not only in predicting formulation-dependent systemic exposure but also the expected
Rodrigo Cristofoletti +2 more
exaly +5 more sources
Virtual Twin Approach Using Physiologically Based Pharmacokinetic Modeling to Support Precision Dosing of Valproic Acid in Geriatric Patients. [PDF]
Clin Pharmacol TherPersonalized dosing is particularly important for drugs with narrow therapeutic indices in geriatric patients, who exhibit substantial physiological variability and limited pharmacokinetic (PK) evidence to guide individualized dose selection. Valproic acid (VPA) is an effective treatment option for bipolar disorder in older adults, yet dosing largely ...
Jang YJ, Heo DG, Hong E.
europepmc +2 more sources
Sex-Related Differences in Physiologically-Based Biopharmaceutics Modeling. [PDF]
CPT Pharmacometrics Syst PharmacolSex‐related differences in gastrointestinal tract physiology and their incorporation into three widely used PBPK platforms (PK‐Sim, GastroPlus, Simcyp) were evaluated. A ketoprofen PBPK model was developed and verified in males, then extrapolated to females using default and sex‐specific refined parameters, demonstrating that user‐defined adjustments ...
Chavarría-Rojas M +4 more
europepmc +2 more sources
Virtual Trial Comparisons and Bioequivalence Assessment: From Data-Based to Probabilistic Assessment [PDF]
, 2023 The recent emergence of virtual trial comparisons, in particular for virtual bioequivalence (VBE) assessment, begs for sound statistical analyses of their results. In recent VBE assessments, pharmacokinetic models informed with in vitro data and verified
Bois, Frederic Yves, Brochot, Céline
core +5 more sources
Reimagining Bioequivalence for the Era of Complex Drug Products: A Quantitative Framework for Generic Drug Development. [PDF]
Clin Transl SciClinical and Translational Science, Volume 19, Issue 7, July 2026.
Dunn A, Lee S, Gobburu JVS.
europepmc +2 more sources
Is a Clinical Trial With a Non-Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK. [PDF]
Clin Pharmacol TherAlthough 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.
Dong J +6 more
europepmc +2 more sources