Physiologically-Based Pharmacokinetic Models of CYP2D6 Substrate and Inhibitors Nebivolol, Cinacalcet and Mirabegron to Simulate Drug–Drug Interactions

Physiologically-Based Pharmacokinetic Models of CYP2D6 Substrate and Inhibitors Nebivolol, Cinacalcet and Mirabegron to Simulate Drug–Drug Interactions

Authors: Kilford P, Khoshaein N, Southall R, Gardner I
Publication: Eur J Drug Metab Pharmacokinet
Keywords: drug-drug interactions (DDIs), metabolism, PBPK models, pharmacokinetics
Division: PBPK

Index substrates and inhibitors to investigate the role of the polymorphic enzyme, cytochrome P450 (CYP) 2D6, in the metabolism of new compounds have been proposed by regulatory agencies.

Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials

Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials

Authors: Maher TM, Ford P, Brown KK, Costabel U, Cottin V, Danoff SK, Groenveld I, Helmer E, Jenkins R, Milner J, Molenberghs G, Penninckx B, Randall MJ, BVD Blink, Fieuw A, Vandenrijn C, Rocak S, Seghers I, Shao L, Taneja A, Jentsch G, Watkins TR, Wuyts WA, Kreuter M, Verbruggen N, Wijsenbeek MS
Publication: JAMA
Keywords: clinical trials, Idiopathic pulmonary fibrosis (IPF), lung fibrosis, nintedanib
Division: PBPK

There is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF).

Leveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary

Leveraging the use of in vitro and computational methods to support the development of enabling oral drug products: An InPharma commentary

Authors: Reppas C, Kuentz M, Bauer-Brandl A, Carlert S, Dallmann A, Dietrich S, Dressman J, Ejskjaer L, Frechen S, Guidetti M, Holm R, Holzem FL, Karlsson E, Kostewicz ES, Panbachi S, Paulus F, Senniksen MB, Stillhart C, Turner DB, Vertzoni M, Vrenken P, Zöller L, Griffin BT, O’Dwyer PJ
Publication: Eur J Pharm Sci
Keywords: amorphous solid dispersions, enabled formulations, gastroplus, in vitro dissolution, pbbm, PBPK modeling, pharmacokinetics, physiologically based biopharmaceutics, sdd
Software: GastroPlus®

Due to the strong tendency towards poorly soluble drugs in modern development pipelines, enabling drug formulations such as amorphous solid dispersions...

Therapeutic Potential and Predictive Pharmaceutical Modeling of Stilbenes in Cannabis sativa

Therapeutic Potential and Predictive Pharmaceutical Modeling of Stilbenes in Cannabis sativa

Authors: O’Croinin C, Guerra AG, Doschak MR, Löbenberg R, Davies NM
Publication: Pharmaceutics
Keywords: anti-cancer, anti-inflammatory, bibenzyl, cannabis, in silico, stilbene
Software: ADMET Predictor®

Cannabis sativa is a plant used for recreational and therapeutic purposes; however, many of the secondary metabolites in the plant have not been thoroughly investigated.

Projection of Target Drug Particle Size in Oral Formulations Using the Refined Developability Classification System (rDCS)

Projection of Target Drug Particle Size in Oral Formulations Using the Refined Developability Classification System (rDCS)

Authors: Beran K, Hermans E, Holm R, Sepassi K, Dressman J
Publication: Pharmaceutics
Keywords: dissolution limitations, oral drug absorption, particle size, permeability, refined developability classification system (rDCS), transit
Software: ADMET Predictor®

Dissolution limitations to oral absorption can occur if the time required for dissolution is longer than the transit time across the small intestine and/or if dissolution is slower than the drug’s permeation through the gut wall.

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: PBPK

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...