Results 1 to 10 of about 644 (112)

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, Bartosz Lisowski, Barbara Wiśniowska, Przemysław Dorożyński, Piotr Kulinowski, Sebastian Polak   +7 more
doaj   +4 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   +5 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, Dejan Krajcar, Tausif Ahmed   +4 more
doaj   +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   +4 more sources

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
doaj   +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
doaj   +4 more sources

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   +3 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.
Frederic Y. Bois, Céline Brochot
doaj   +4 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   +4 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 J, 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
Bego M, Patel N, Cristofoletti R, Rostami-Hodjegan A.   +3 more
europepmc   +4 more sources