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: Clinical Pharmacology and Pharmacometrics (CPP)

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...

Population pharmacokinetics of vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for treatment of anemia associated with chronic kidney disease

Population pharmacokinetics of vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor for treatment of anemia associated with chronic kidney disease

Authors: Roberts JK, Navarro-Gonzales P, Humphrey RL, Bihorel S, Dykstra, K
Conference: PAGE
Keywords: anemia, chronic kidney disease, pop PK, population PK, Vadadustat
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, a class of...

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.

Evaluation of the anticancer potential of CD44 targeted vincristine nanoformulation in prostate cancer xenograft model: a multi-dynamic approach for advanced pharmacokinetic evaluation

Evaluation of the anticancer potential of CD44 targeted vincristine nanoformulation in prostate cancer xenograft model: a multi-dynamic approach for advanced pharmacokinetic evaluation

Authors: Naseer F, Kousar K, Abduh MS, Anjum S, Ahmad T
Publication: Cancer Nanotechnology
Keywords: admet predictor, anticancer, machine learning PBPK QST(P) marriage, pharmacokinetic evaluation, vincristine
Software: ADMET Predictor®

The in vivo anticancer potential of vincristine (VC) loaded, thiolated chitosan-based nanoformulation (NFs) with an outer hyaluronic acid (VC-loaded in TCs-HA) coating was studied in prostate cancer (PC) xenograft in the immunosuppressed rat model induced by PC3 cell lines.

The application of AI-driven Drug Discovery technology for molecular optimization of nuclear receptor ligands

The application of AI-driven Drug Discovery technology for molecular optimization of nuclear receptor ligands

Authors: Bachorz RA
Conference: Ninth Joint Sheffield Conference on Chemoinformatics
Keywords: admet predictor, AIDD, de novo drug design, molecular optimization, pharmacokinetic (PK) properties
Software: ADMET Predictor®
Division: PBPK

Nuclear receptors (NRs) are a superfamily of transcription factors whose activity is regulated upon the binding of a specific ligand.

Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies

Predictive Potential of Acido-Basic Properties, Solubility and Food on Bioequivalence Study Outcome: Analysis of 128 Studies

Authors: Krajcar D, Jereb R, Legen I, Opara J, Grabnar I
Publication: Drugs in R&D
Keywords: admet predictor, gastroplus, machine learning, Peff, pKa, property prediction
Software: GastroPlus®

Risk assessment related to bioequivalence study outcome is critical for effective planning from the early stage of drug product development.