Physiologically based pharmacokinetic (PBPK) modelling of oral drug absorption in older adults – an AGePOP review

Physiologically based pharmacokinetic (PBPK) modelling of oral drug absorption in older adults – an AGePOP review

Authors: Demeester C, Robins D, Edwina AE, Tournoy J, Augustijns P, Ince I, Lehmann A, Vertzoni M, Schlender JF
Publication: Eur J Pharm Sci
Keywords: gastroplus, geriatrics, gi tract, mechanistic absorption, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

The older population consisting of persons aged 65 years or older is the fastest-growing population group and also the major consumer of pharmaceutical products.

In silico modeling as a support tool in the development of new products in the generic pharmaceutical industry: case studies of the application of DDDPlus™ and GastroPlus® software

In silico modeling as a support tool in the development of new products in the generic pharmaceutical industry: case studies of the application of DDDPlus™ and GastroPlus® software

Authors: Martins F, de Souza RRC
Keywords: dddplus, gastroplus, generic drugs, in silico modeling
Software: DDDPlus™, GastroPlus®
Division: Simulations Plus

During this webinar, we will shed light on the key benefits and practical implications of utilizing in silico modeling for formulation optimization, biopharmaceutical predictions, and bioequivalence studies

PBPK Modeling as an Alternative Method of Interspecies Extrapolation that Reduces the Use of Animals: A Systematic Review

PBPK Modeling as an Alternative Method of Interspecies Extrapolation that Reduces the Use of Animals: A Systematic Review

Authors: Dayana Lancheros K, Alves I, Aragón M
Publication: Curr Med Chem
Keywords: fih, FIHSimulator, first-in-human, gastroplus, IVIVE, PBPK modeling, physiologically based pharmacokinetics, risk assessment, translational science
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) modeling is a computational approach that simulates the anatomical structure of the studied species...

Integrated in vitro – in vivo – in silico studies in the pharmaceutical development of propranolol hydrochloride mucoadhesive buccal films

Integrated in vitro – in vivo – in silico studies in the pharmaceutical development of propranolol hydrochloride mucoadhesive buccal films

Authors: Kurcubic I, Djuriš J, Cvijić S, Crevar M, Ibric S, Miloradovic Z, Mihailovic-Stanojevic N, Karanovic D, Ivanov M, Jovovic D, Vajic UJ
Publication: J Drug Deliv Sci Technol
Keywords: biopharmaceutics, gastroplus, intraoral, oral cavity, pbbm, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

In order to exploit the advantage of drug delivery through the buccal mucosa, mucoadhesive buccal films with propranolol hydrochloride based on polyethylene oxide...

Population Pharmacokinetics and Exposure-Response Analysis of a Single Dose of Sotrovimab in the Early Treatment of Patients With Mild to Moderate COVID-19

Population Pharmacokinetics and Exposure-Response Analysis of a Single Dose of Sotrovimab in the Early Treatment of Patients With Mild to Moderate COVID-19

Authors: Sager JE, El-Zailik A, Passarell JA, Roepcke S, Li X, Aldinger M, Nader A, Skingsley A, Alexander E, Yeh W, Mogalian E, Garner C, Peppercorn A, Shapiro A, Reyes M
Publication: CPT Pharmacometrics Syst Pharmacol
Keywords: exposure-response, infectious disease, monoclonal antibodies, population pharmacokinetics, sotrovimab
Division: Cognigen

Sotrovimab is a recombinant human monoclonal antibody that has been shown to prevent progression to hospitalization or death in non-hospitalized high-risk patients with mild to moderate...

Revisiting the in-vitro and in-vivo considerations for in-silico modelling of complex injectable drug products

Revisiting the in-vitro and in-vivo considerations for in-silico modelling of complex injectable drug products

Authors: Dabke A, Ghosh S, Dabke P, Sawant K, Khopade A
Publication: J Control Release
Keywords: biopharmaceutics, gastroplus, in vitro-in vivo correlations, IVIVC, lai, Long Acting Injectable, machine learning PBPK QST(P) marriage, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

Complex injectable drug products (CIDPs) have often been developed to modulate the pharmacokinetics along with efficacy for therapeutic agents used for remediation of chronic disorders.

Modeling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies

Modeling Based Approaches to Support Generic Drug Regulatory Submissions-Practical Considerations and Case Studies

Authors: Karnati P, Murthy A, Gundeti M, Ahmed T
Publication: AAPS J
Keywords: biowaivers, gastroplus, generic drugs, pbbm, PBPK modeling, physiologically based biopharmaceutics, regulatory interactions, vbe, virtual bioequivalence
Software: GastroPlus®

Model informed drug development (MiDD) is useful to predict in vivo exposure of drugs during various stages of the drug development process. This approach employs a variety of quantitative tools to assess the risks during the drug development process.