Integrating Forward and Reverse Translation in PBPK Modeling to Predict Food Effect on Oral Absorption of Weakly Basic Drugs

Integrating Forward and Reverse Translation in PBPK Modeling to Predict Food Effect on Oral Absorption of Weakly Basic Drugs

Authors: Franco YL, Da Silva L, Charbe N, Kinvig H, Kim S, Cristofoletti R
Publication: Pharm Res
Keywords: biopharmaceutics, drug product specifications, food effect, gastroplus, in vitro dissolution, pbbm, PBPK modeling, physiologically based pharmacokinetics, virtual bioequivalence
Software: GastroPlus®
Division: PBPK

Ketoconazole and posaconazole are two weakly basic broad-spectrum antifungals classified as Biopharmaceutics Classification System class II drugs, indicating that they are...

Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039

Establishing the Safe Space via Physiologically Based Biopharmaceutics Modeling. Case Study: Fevipiprant/QAW039

Authors: Kourentas A, Gajewska M, Lin W, Dhareshwar SS, Steib-Lauer C, Kulkarni S, Hirsch S, Heimbach T, Mueller-Zsigmondy M
Publication: AAPS J
Keywords: biopharmaceutics, drug product specifications, gastroplus, in vitro dissolution, pbbm, PBPK modeling, physiologically based pharmacokinetics, virtual bioequivalence
Software: GastroPlus®

Physiologically based pharmacokinetic and absorption modeling has increasingly been implemented for biopharmaceutics applications to define the safe space for drug...

Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation under Fed and Fasting Conditions

Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation under Fed and Fasting Conditions

Authors: Subhani S, Lukacova V, Kim C, Rodriguez-Vera L, Muniz P, Rodriguez M, Cristofoletti R, Van Os S, Suarez E, Schmidt S, Vozmediano V
Publication: Pharmaceutics
Keywords: biopharmaceutics, drug product specifications, food effect, gastroplus, pbbm, PBPK modeling, physiologically based pharmacokinetics, virtual bioequivalence
Software: GastroPlus®
Division: PBPK

Paliperidone was approved by the US FDA in 2006 as an extended-release (ER) tablet (Invega®) for the once-daily treatment of schizophrenia. This osmotic-controlled...

Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union

Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union

Authors: Garcia-Arieta A, Gordon J, Gwaza L, Merino V, Mangas-Sanjuán V
Publication: Pharmaceutics
Keywords: biowaiver, complex formulation, cutaneous, microstructure, qualitative samenes, quantitative similarity, simple formulation, stepwise approach, topical

The development of second-entry topical products is hampered by several factors.

Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

Authors: Kollipara S, Bhattiprolu AK, Boddu R, Ahmed T, Chachad S
Publication: AAPS PharmSciTech
Keywords: biopharmaceutics, dddplus, drug product specifications, gastroplus, in vitro method, pbbm, PBPK modeling, physiologically based pharmacokinetics, virtual bioequivalence
Software: GastroPlus®

Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives...