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
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
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).

Formulation Development and Evaluation, in silico PBPK Modeling and in vivo Pharmacodynamic Studies of Clozapine Matrix Type Transdermal Patches
Clozapine is a potent serotonin receptor antagonist and commonly used for the treatment of Schizophrenia.

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

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report
This report summarizes the proceedings for Day 3 of the workshop titled “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.

Predicting Pharmacokinetics of Active Constituents in Spatholobi caulis by Using Physiologically Based Pharmacokinetic Models
Spatholobi Caulis (SPC) is a medicinal plant that mainly grows in China and Southeast Asian countries and commonly used in clinics; the pharmacokinetic characteristics in humans need to be determined.

Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack
Mesalamine is a locally acting anti-inflammatory drug used to treat mild to moderate ulcerative colitis.

The Role of Carotenoids from Red Mamey Fruit (Pouteria sapota) Against Amyloid-β Monomers in Alzheimer’s Disease: Computational Analysis and ADMET Prediction
Carotenoids, potent antioxidants in fruits and vegetables, have recently garnered attention for their potential therapeutic effects against neurodegenerative diseases.

Hydrogel for Sustained Delivery of Therapeutic Agents
In recent years, hydrogels have emerged as a highly promising platform for the sustained delivery of therapeutic agents, addressing critical challenges in drug delivery systems, from controlled release to biocompatibility.

Synthesis and Structure–Activity Relationship of Thiourea Derivatives Against Leishmania Amazonensis
Leishmaniasis, caused by Leishmania protozoa and transmitted by vectors, presents varied clinical manifestations based on parasite species and host immunity. The lack of effective vaccines or treatments has prompted research into new therapies, including thiourea derivatives, which have demonstrated antiprotozoal activities.

Advancing understanding of human variability through toxicokinetic modeling, in vitro-in vivo extrapolation, and new approach methodologies
The merging of physiology and toxicokinetics, or pharmacokinetics, with computational modeling to characterize dosimetry has led to major advances for both the chemical and pharmaceutical research arenas.

A review of quantitative structure-activity relationship: The development and current status of data sets, molecular descriptors and mathematical models
Developing Quantitative Structure-Activity Relationship (QSAR) models applicable to general molecules is of great significance for molecular design in many disciplines.

Formulation development, characterization, and mechanistic PBPK modeling of metoclopramide loaded halloysite nanotube (HNT) based drug-in-adhesive type transdermal drug delivery system
Metoclopramide is an antiemetic agent prescribed for motion sickness, cancer chemotherapy, and pregnancy.

Investigation of the Anti-asthmatic Activity of Solidagenone, In Vitro Toxicity Versus In Silico Studies
Solidagenone, a labdane diterpene isolated from inflorescences of Solidago chilensis Meyen, Asteraceae, was investigated for its anti-inflammatory and anti-asthmatic action.

Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass
Bariatric surgery introduces significant changes in the gastrointestinal tract, which may affect oral drug absorption/bioavailability.