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
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...
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.
Pregabalin (PGB) is widely used clinically; however, its pharmacokinetics (PK) has not been studied in pediatric patients with renal impairment (RI).
The importance of closely observing patients receiving antibiotic therapy, performing therapeutic drug monitoring (TDM), and regularly adjusting dosing regimens has been extensively demonstrated.
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.
For children, a special population who are continuously developing, a reasonable dosing strategy is the key to clinical therapy.
Free access to Simulations Plus software for accredited universities will accelerate learning and educational pursuits
Highly variable disposition after oral ingestion of acyclovir has been reported, although little is known regarding the underlying mechanisms.
A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor.
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
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).
DDDPlus provides complex models to handle: membrane dissolution, biphasic dissolution and artificial stomach duodenum test.
Nonalcoholic steatohepatitis (NASH) is a growing clinical concern, but currently there is no approved medicine for treatment of NASH. Fibroblast growth...
Glucuronidation is considered a major metabolic pathway for drugs containing carboxylic acid, hydroxyl, and amine moieties [1].
Discuss advances made with PBPK modeling for both oral and non-oral routes for the first in human predictions
Providing a case for why you should focus on preclinical verification when using Physiologically Based Pharmacokinetic (PBPK) modeling for First-In-Human (F.I.H) pharmacokinetic predictions.
Obeticholic acid (OCA), a bile acid analog and agonist of the farnesoid X receptor (FXR), is currently in clinical trials...
The work outlined herein describes an evaluation of a green solvent working as a drug solubility and penetration enhancer made up of a deep eutectic system (DES) composed of menthol (MN) and capric acid (CA).
