Results 1 to 10 of about 640 (99)

A mechanistic physiologically based model to assess the effect of study design and modified physiology on formulation safe space for virtual bioequivalence of dermatological drug products [PDF]

Frontiers in Pharmacology, 2022
Physiologically based pharmacokinetic (PBPK) models are widely accepted tools utilised to describe and predict drug pharmacokinetics (PK). This includes the use of dermal PBPK models at the regulatory level including virtual bioequivalence (VBE) studies.
J. F. Clarke, J. F. Clarke, K. Thakur, S. Polak, S. Polak   +4 more
exaly   +4 more sources

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook [PDF]

Pharmaceuticals
Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product. However, bioequivalence studies represent significant complexities due to the interplay of multiple factors related to ...
Sivacharan Kollipara, Frederico Severino Martins, Rebeka Jereb   +2 more
exaly   +4 more sources

Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry [PDF]

Pharmaceutics
Background/Objectives: The rise of virtual bioequivalence studies has transformed the pharmaceutical landscape, enabling more efficient drug development processes.
Nasser Alotaiq, Doni Dermawan, Alotaiq Nasser   +2 more
exaly   +4 more sources

Can 3D Printed Tablets Be Bioequivalent and How to Test It: A PBPK Model Based Virtual Bioequivalence Study for Ropinirole Modified Release Tablets [PDF]

Pharmaceutics
As the field of personalized dosing develops, the pharmaceutical manufacturing industry needs to offer flexibility in terms of tailoring the drug release and strength to the individual patient’s needs.
Olha Shuklinova, Gabriela Wyszogrodzka-Gaweł, Ewelina Baran   +2 more
exaly   +4 more sources

A Bayesian framework for virtual comparative trials and bioequivalence assessments [PDF]

Frontiers in Pharmacology
IntroductionIn 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.
Celine Brochot, Frédéric Y Bois, Bois Frédéric Y   +2 more
exaly   +4 more sources

From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlus^®-Driven Framework for Generic Candesartan Cilexetil Tablets [PDF]

Pharmaceuticals
Background: Candesartan cilexetil, a Biopharmaceutics Classification System (BCS) II prodrug, demonstrates compromised bioavailability attributable to its limited aqueous solubility coupled with P-glycoprotein (P-gp)-mediated efflux and hepatic first ...
Hao Ruan, Xiaoting Geng, Zijing Situ, Qian Shen, Tianjian Ye, Xin Chen, Weike Su   +6 more
doaj   +2 more sources

Physiologically-Based Biopharmaceutics Modeling for Ibuprofen: Identifying Key Formulation Parameter and Virtual Bioequivalence Assessment [PDF]

Pharmaceutics
Background: Physiologically based pharmacokinetic (PBPK) modeling for biopharmaceutics applications (i.e., physiologically based biopharmaceutics modeling (PBBM)) enables mechanistic modeling from dissolution to absorption and disposition, facilitating ...
Javier Zarzoso-Foj, Marina Cuquerella-Gilabert, Matilde Merino-Sanjuan, Javier Reig-Lopez, Víctor Mangas-Sanjuán, Alfredo Garcia-Arieta   +5 more
doaj   +2 more sources

Virtual Bioequivalence Assessment and Dissolution Safe Space Exploration for Fixed-Dose Metformin–Glyburide Tablet Using Physiologically Based Biopharmaceutics Modeling [PDF]

Pharmaceutics
Background/Objectives: Fixed-dose combinations (FDCs) hold significant clinical value for the management of hypertension, diabetes and other chronic diseases.
Chenshuang Zhao, Chaozhuang Shen, Yumeng Xiao, Ling Wang   +3 more
doaj   +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 Ther
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.
Dong J, Moir A, Pepin X, Lowe E, Hopkins S, Tang W, Zhou D.   +6 more
europepmc   +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