The emerging field of bioelectricity has revealed numerous new roles for ion channels beyond the nervous system, which can be exploited for applications in regenerative medicine.
PBPK Absorption Modeling: Establishing the In Vitro–In Vivo Link—Industry Perspective
The establishment of an in vitro–in vivo correlation (IVIVC) is considered the gold standard to establish in vivo relevance of a dissolution method and to utilize dissolution data in the context of regulatory bioequivalence questions...
DILIsym Awarded $1.5 Million Phase II NIH Grant
Phase II Award of NIH Fast Track SBIR Grant for Drug-induced Kidney Injury Software, RENAsym™, Funds Development Over Next 20 Months
Molecular Determinants of Cell Permeability Beyond the Rule of 5
Molecules that violate conventional guidelines for druglikeness—such as the Rule-of-5—are of increasing interest as chemical probes and drugs for intractable pharmacological targets.
Simulations Plus Releases DDDPlus™ Version 6
New models for in vitro systems lead to improved inputs for GastroPlus® simulations
DILIsym Services Inc. Initiates Development of IPFsym™
New idiopathic pulmonary fibrosis QSP platform to enable more efficient drug development
Simulations Plus Reports First Quarter FY2019 Financial Results
First quarter net revenues of $7.5 million reflecting 6.6% year over year growth. Board of Directors announces quarterly dividend of $0.06 per share
PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development
Prediction of the effect of food on drug’s pharmacokinetics using modeling and simulation could cause difficulties due to complex in vivo processes.
Support files in GastroPlus®
This video discusses support files in GastroPlus™.
DILIsym Services Inc. Releases DILIsym® Version 8A
Substantial update of liver safety software includes new science and practical extensions
Simulations Plus to Report First Quarter Fiscal Year 2019 Financial Results
Conference Call to be on Wednesday, January 9, 2019, at 4:15 p.m. EST
Predicting the Effects of Different Triazole Antifungal Agents on the Pharmacokinetics of Tamoxifen
Tamoxifen is an antiestrogen drug that is widely used in the adjuvant chemotherapy of estrogen receptor-α (ERα)-positive breast cancer.
A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme
The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally.
Model-Informed Drug Development for Malaria Therapeutics
Malaria is a critical public health problem resulting in substantial morbidity and mortality, particularly in developing countries.
Design, synthesis, biological evaluation, structure-activity relationship, and toxicity of clinafloxacin-azole conjugates as novel antitubercular agents
Based on the advantages of azole molecules and fluoroquinolone drugs, we designed and synthesized 34 clinafloxacin-azole conjugates using fragment-based drug design and drug combination principles.
Development of a population pharmacokinetic model for taranabant, a cannibinoid-1 receptor inverse agonist
Taranabant is a cannabinoid-1 receptor inverse agonist developed for the treatment of obesity.
Symptomatic cardiotoxicity associated with 5-fluorouracil
A prospective cohort study was conducted in 35 hospitals with oncology units to determine the incidence of symptomatic cardiotoxicity in patients receiving...
Relationship between drug exposure and the efficacy and safety of bupropion sustained release for smoking cessation
A population pharmacokinetic and pharmacodynamic analysis evaluated the relationships of dose, plasma concentrations of bupropion and metabolites...