Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling

Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling

Publication: AAPS J
Software: GastroPlus®
Division: PBPK

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.

Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies

Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies

Authors: Garcia-Arieta A

One of the significant challenges faced by pharmaceutical companies is the sometimes unclear guidance on what data regulators want to see included in their submissions and the format in which it should be provided.

Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation

Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation

Publication: Pharmaceutics
Software: GastroPlus®
Division: PBPK

The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs.

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

Advancing Virtual Bioequivalence for Orally Administered Drug Products: Methodology, Real-World Applications and Future Outlook

Publication: Pharmaceuticals
Software: GastroPlus®
Division: PBPK

Bioequivalence studies are pivotal in generic drug development wherein therapeutic equivalence is provided with an innovator product.

Toward Personalized Salbutamol Therapy: Validating Virtual Patient-Derived Population Pharmacokinetic Model with Real-World Data

Toward Personalized Salbutamol Therapy: Validating Virtual Patient-Derived Population Pharmacokinetic Model with Real-World Data

Authors: Marques L, Vale N
Publication: Pharmaceutics
Software: GastroPlus®
Division: PBPK

Interindividual variability, influenced by patient-specific factors including age, weight, gender, race, and genetics, among others, contributes to variations in therapeutic response.