Asciminib is a first-in-class inhibitor of BCR::ABL1, specifically targeting the ABL myristoyl pocket. Asciminib is a substrate of CYP3A4 and P-glycoprotein (P-gp) and possesses pH-dependent solubility in aqueous solution.
PBPK Modeling of Pulmonary Drug Absorption: Challenges & Perspective
PBPK models that describe drug performance following pulmonary administration, like the PCAT™ model within GastroPlus(R), have appeared more recently, yet few pieces of literature report on their use.
Simulations Plus and the University of Connecticut Awarded New FDA Contract to Accelerate the Development of Long-Acting Injectable Products
Collaboration will combine novel experimental techniques and mechanistic modeling strategies
Physiologically Based Pharmacokinetic Modeling of Oxycodone in Children to Support Pediatric Dosing Optimization
Physiologically-based pharmacokinetic (PBPK) modeling offers a unique modality to predict age-specific pharmacokinetics.
Simulations Plus Reports Fourth Quarter and Full Year Fiscal 2021 Results
Fiscal 2021 revenue increased 12% year-over-year to $46.5 million
Software revenue increased 28% year-over-year to $27.7 million
Fiscal 2022 financial outlook for total revenue of $51 million to $53 million, reflecting 10% to 15% year-over-year growth
In silico bioavailability for BCS class II efavirenz tablets using biorelevant dissolution media for IVIVR and simulation of formulation changes
This work aims to evaluate the ability of biorelevant dissolution media to simulate the bioavailability of efavirenz tablets, establish an in vitro–in vivo relationship (IVIVR) based on in...
Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms.
Development of Physiologically Based Pharmacokinetic Model for Pregabalin to Predict the Pharmacokinetics in Pediatric Patients with Renal Impairment and Adjust Dosage Regimens
Pregabalin (PGB) is widely used clinically; however, its pharmacokinetics (PK) has not been studied in pediatric patients with renal impairment (RI).
PBPK Modeling and Simulation of Antibiotics Amikacin, Gentamicin, Tobramycin, and Vancomycin Used in Hospital Practice
The importance of closely observing patients receiving antibiotic therapy, performing therapeutic drug monitoring (TDM), and regularly adjusting dosing regimens has been extensively demonstrated.
Animal metrics: Tracking contributions of new approach methods to reduced animal use
Many companies and global regulatory programs have expressed the intent to move away from in vivo animal testing to new approach methods (NAMs) as part of product safety assessments.
Optimization of Personalized Amlodipine Dosing Strategies for Children Based on Pharmacokinetic Data from Chinese Male Adults and PBPK Modeling
For children, a special population who are continuously developing, a reasonable dosing strategy is the key to clinical therapy.
Simulations Plus Announces the University+ Program
Free access to Simulations Plus software for accredited universities will accelerate learning and educational pursuits
Predicting pharmacokinetics of multisource acyclovir oral products through physiologically based biopharmaceutics modeling
Highly variable disposition after oral ingestion of acyclovir has been reported, although little is known regarding the underlying mechanisms.
Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-Space for Ribociclib which has Permeation Rate-Controlled Absorption
A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor.
Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study
Development of generic ophthalmic drug products is challenging due to the complexity of the ocular system and a lack of sensitive testing tools to evaluate its interplay with ophthalmic formulations
Assessing the Potential for Hepatotoxicity for Combination Therapy of Valproate (VPA) and Cannabidiol (CBD) using Quantitative Systems Toxicology (QST)
Highly purified cannabidiol (CBD) (approved as Epidiolex in the US) is efficacious in treating seizures associated with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and Tuberous Sclerosis Complex (TSC).
In Vivo Extrapolation of Precipitation with Complex Dissolution Experiments
DDDPlus provides complex models to handle: membrane dissolution, biphasic dissolution and artificial stomach duodenum test.