Results 1 to 10 of about 686 (95)

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

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

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

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   +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

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

Virtual bioequivalence-guided PBBM prediction for ibuprofen/diphenhydramine citrate tablets: impact of dissolution variability and clinical standard development [PDF]

Saudi Pharmaceutical Journal
This study aimed to integrate in vitro dissolution testing, in vivo pharmacokinetic (PK) studies, and computational simulation to develop a physiologically based biopharmaceutics model (PBBM) for fixed-dose combination ibuprofen/diphenhydramine citrate ...
Zilong Wang, Zhihai Cao, Chun Guo, Qian Zhang, Renpeng Zhou, Jian Chen, Feng Su, Wei Liu, Zhaoxing Chu, Liang Zheng, Wei Hu   +10 more
doaj   +2 more sources

A PBPK-VBE approach for bioequivalence extrapolation of senaparib capsule strengths in the context of nonlinear pharmacokinetics: bridging from the clinical starting dose to the linear pharmacokinetic range [PDF]

Frontiers in Pharmacology
AimsSenaparib (Sepalna®), a novel oral poly (adenosine diphosphate -ribose) polymerase (PARP) 1/2 inhibitor, was approved in China in 2025 as maintenance therapy for advanced ovarian cancer.
Xiaofei Wu, Ziyang Wang, Yanna He, Keheng Wu, Bo Liu, Bo Liu, Ning Ma, Suixiong Cai, Cong Xu, Yanhua Xu, Shiqing Zhao, Hongyun Wang   +11 more
doaj   +2 more sources

Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing [PDF]

Pharmaceutics
Background/Objectives: Narrow therapeutic index (NTI) drugs are characterized by a small margin between effective and toxic exposure. This review aimed to summarize international definitions and regulatory frameworks for NTI drugs, compare bioequivalence
Mengmeng Liu, Zhe Wang, Yongbo Chen, Yuqi Jia, Lei Xu, Haojie Xu, Jueyu Li, Libo Zhao   +7 more
doaj   +2 more sources