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Journal of Pharmaceutical Sciences, 2022 S.135-145The objective of the present study was to develop a physiologically based biopharmaceutics (PBBM) approach to predict the bioequivalence of dosage forms containing poorly soluble drugs.
Jennifer Dressman, Atsushi Kambayashi
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Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption [PDF]
Journal of Pharmaceutical Sciences, 2022 A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor. Ribociclib is a weak base with moderate permeability and complete in vitro dissolution under stomach pH. GastroPlus™ was used to simulate the pharmacokinetics (PK) in healthy volunteers
Yan Ji +2 more
exaly +3 more sources
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AAPS Journal, 2023
In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in vitro dissolution data to test for virtual bioequivalence.
Mohamad Shebley +2 more
exaly +3 more sources
In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in vitro dissolution data to test for virtual bioequivalence.
Mohamad Shebley +2 more
exaly +3 more sources
Clinical Pharmacokinetics, 2021
Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is well recognized to be the future of the physiologically based pharmacokinetic model ...
Ji Jiang, Fan Zhang
exaly +3 more sources
Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is well recognized to be the future of the physiologically based pharmacokinetic model ...
Ji Jiang, Fan Zhang
exaly +3 more sources
Molecular Pharmaceutics, 2022
To evaluate the influence of solubility and permeability on the pharmacokinetic prediction performance of orally administered drugs using avirtual bioequivalence (VBE) model, a total of 23 orally administered drugs covering Biopharmaceutics Classification System (BCS) classes 1-4 were selected. A VBE model (i.e., a physiologically based pharmacokinetic
Fan Zhang +5 more
openaire +2 more sources
To evaluate the influence of solubility and permeability on the pharmacokinetic prediction performance of orally administered drugs using avirtual bioequivalence (VBE) model, a total of 23 orally administered drugs covering Biopharmaceutics Classification System (BCS) classes 1-4 were selected. A VBE model (i.e., a physiologically based pharmacokinetic
Fan Zhang +5 more
openaire +2 more sources
AAPS JournalAbstractRitlecitinib, an orally available Janus kinase 3 and tyrosine kinase inhibitor being developed for the treatment of alopecia areata (AA), is highly soluble across the physiological pH range at the therapeutic dose. As such, it is expected to dissolve rapidly in any in vitro dissolution conditions.
Martin E Dowty, Kazuko Sagawa
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Journal of Pharmaceutical Sciences
We prospectively conducted virtual bioequivalence (VBE) trials under fasted conditions to guide a clinical trial design and candidate selection for a model drug with a long elimination half-life. We combined biopredictive dissolution methods that mimic gastric motility with innovative biopharmaceutical modeling, enabling suitability checks of crossover
Dorota Danielak +14 more
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We prospectively conducted virtual bioequivalence (VBE) trials under fasted conditions to guide a clinical trial design and candidate selection for a model drug with a long elimination half-life. We combined biopredictive dissolution methods that mimic gastric motility with innovative biopharmaceutical modeling, enabling suitability checks of crossover
Dorota Danielak +14 more
openaire +2 more sources
The AAPS Journal
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used.
Ruwei Yang +10 more
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Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used.
Ruwei Yang +10 more
openaire +2 more sources
Journal of Pharmaceutical Sciences, 2017
Postabsorptive factors which can affect systemic drug exposure are assumed to be dependent on the active pharmaceutical ingredient (API), and thus independent of formulation. In contrast, preabsorptive factors, for example, hypochlorhydria, might affect systemic exposure in both an API and a formulation-dependent way.
Rodrigo, Cristofoletti +2 more
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Postabsorptive factors which can affect systemic drug exposure are assumed to be dependent on the active pharmaceutical ingredient (API), and thus independent of formulation. In contrast, preabsorptive factors, for example, hypochlorhydria, might affect systemic exposure in both an API and a formulation-dependent way.
Rodrigo, Cristofoletti +2 more
openaire +2 more sources
The AAPS Journal
Typically, parent drug is measured for bioequivalence (BE) assessment because it's more sensitive to detect formulation differences, compared to its metabolite(s). For simvastatin immediate release (IR) tablets, current product-specific guidance (PSG) recommends measuring both parent and metabolite but taking metabolite as supportive data.
Yi-Hsien Cheng +4 more
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Typically, parent drug is measured for bioequivalence (BE) assessment because it's more sensitive to detect formulation differences, compared to its metabolite(s). For simvastatin immediate release (IR) tablets, current product-specific guidance (PSG) recommends measuring both parent and metabolite but taking metabolite as supportive data.
Yi-Hsien Cheng +4 more
openaire +2 more sources