In vivo Performance of Amorphous Solid Dispersions Based on Water-Insoluble Versus Water-Soluble Carriers: Fenofibrate Case Study

In vivo Performance of Amorphous Solid Dispersions Based on Water-Insoluble Versus Water-Soluble Carriers: Fenofibrate Case Study

Publication: Int J Pharm
Software: GastroPlus®
Division: PBPK

The objective of this study is to address the unanswered question whether sustained supersaturation generated from amorphous solid dispersions (ASDs) formulated in insoluble hydrogel carriers will result in better bioavailability over that of spring-and-parachute type of dissolution profiles of ASDs formulated in water-soluble carriers

Dosage Optimization Using Physiologically Based Pharmacokinetic Modeling for Pediatric Patients with Renal Impairment: A Case Study of Meropenem

Dosage Optimization Using Physiologically Based Pharmacokinetic Modeling for Pediatric Patients with Renal Impairment: A Case Study of Meropenem

Publication: AAPS PharmSciTech
Software: GastroPlus®
Division: PBPK

The pharmacokinetics of renally eliminated antibiotics can be influenced by changes associated with renal function and development in a growing subject. Little is known about the effects of renal insufficiency on the pharmacokinetics of meropenem in pediatric subjects.

Association Between Abatacept Exposure Levels and Infection Occurrence in Patients with Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study

Association Between Abatacept Exposure Levels and Infection Occurrence in Patients with Rheumatoid Arthritis: Post Hoc Analysis of the AVERT-2 Study

Publication: The Journal of Rheumatology
Therapeutic Areas: Rheumatology

 To determine if higher serum exposure during subcutaneous (SC) abatacept treatment was associated with an increased infection risk in adult patients with early rheumatoid arthritis (RA).

Improving Individualized Salbutamol Treatment: A Population Pharmacokinetic Model for Oral Salbutamol in Virtual Patients

Improving Individualized Salbutamol Treatment: A Population Pharmacokinetic Model for Oral Salbutamol in Virtual Patients

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

Salbutamol, a short-acting β2-agonist used in asthma treatment, is available in multiple formulations, including inhalers, nebulizers, oral tablets, and intravenous, intramuscular, and subcutaneous routes.

Characterization of Preclinical Radio ADME Properties of ARV-471 for Predicting Human PK Using PBPK Modeling

Characterization of Preclinical Radio ADME Properties of ARV-471 for Predicting Human PK Using PBPK Modeling

Publication: J Pharm Analysis
Software: GastroPlus®
Division: PBPK

Proteolysis-targeting chimeras (PROTACs) represent a promising class of drugs that can target disease-causing proteins more effectively than traditional small molecule inhibitors can, potentially revolutionizing drug discovery and treatment strategies.

Advancing Systemic Toxicity Risk Assessment: Evaluation of a NAM-based Toolbox Approach

Advancing Systemic Toxicity Risk Assessment: Evaluation of a NAM-based Toolbox Approach

Publication: Toxicol Sci
Software: GastroPlus®
Division: PBPK

For many years, a method that allowed systemic toxicity safety assessments to be conducted without generating new animal test data, seemed out of reach.

Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules

Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules

Publication: AAPS PharmSciTech
Software: GastroPlus®
Division: PBPK

A slight variation in in vivo exposure for tacrolimus extended-release (ER) capsules, which have a narrow therapeutic index (NTI), significantly affects the pharmacodynamics of the drug. Generic drug bioequivalence (BE) standards are stricter, necessitating accurate assessment of the rate and extent of drug release.

Advancements in Ocular Modelling and Simulations: Key Considerations and Case Studies

Advancements in Ocular Modelling and Simulations: Key Considerations and Case Studies

Authors: Khan MS, Murthy A, Ahmed T
Publication: AAPS PharmSciTech
Software: GastroPlus®
Division: PBPK

This review paper discusses the key aspects of ocular biopharmaceutics, with emphasis on the crucial role played by ocular compartmental modelling and simulation in deciphering physiological conditions related to various eye diseases.