In part one of this complement blog series, the complement cascade and its role in various diseases was introduced, as well as the potential for mechanistic modeling to support development of complement‑targeted therapeutics. COMPLEMENTsym, a quantitative systems pharmacology (QSP) model of complement focused on the alternative and terminal pathways (AP, TP, respectively) was introduced.
Comparison of drug-induced liver injury risk between propylthiouracil and methimazole: A quantitative systems toxicology approach
Propylthiouracil (PTU) and methimazole (MMI), two classical antithyroid agents possess risk of drug-induced liver injury (DILI) with unknown mechanism of action.
Redefining Statin Dosage Post-Gastric Bypass: Insights from a Population Pharmacokinetics–Pharmacodynamics Link Approach
Roux-en-Y gastric bypass (RYGB) involves creating a small stomach pouch, bypassing part of the small intestine, and rerouting the digestive tract.
Scaling approaches for the prediction of human clearance of LNA-i-mir-221: A retrospective validation
LNA-i-miR-221 is a novel microRNA(miRNA)-221 inhibitor designed for the treatment of human malignancies.
Simulations Plus Releases DILIsym® X
Updated quantitative systems toxicology (QST) software investigates and predicts drug-induced liver injury (DILI)
Don’t Wait Until Phase III: Why Early DILI Prediction is Key to Drug Development Success
As anyone who has worked in the pharmaceutical industry for awhile can tell you, there are many challenges, but one in particular keeps many of us up at night – the specter of drug-induced liver injury (DILI) lurking later in the drug development process.
Simulations Plus Releases ADMET Predictor® Version 12
Enhancements in key models power HT-PBPK simulations and AI-driven drug design with unprecedented performance and accuracy.
ADMET Predictor®12: Predict with Confidence
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Computational approach for drug discovery against Gardnerella vaginalis in quest for safer and effective treatments for bacterial vaginosis
Bacterial vaginosis (BV), primarily attributed to Gardnerella vaginalis, poses significant challenges due to antibiotic resistance and suboptimal treatment outcomes.
Development and Application of a Physiologically Based Pharmacokinetic Model for Elagolix in the Adult and Adolescent Population
Endometriosis, a common and distressing gynecological condition, affects fertility and causes pain, is often managed with medications such as Elagolix.
Oral Absorption from Surfactant-Based Drug Formulations: The Impact of Molecularly Dissolved Drug on Bioavailability
Enabling drug formulations are often required to ensure sufficient absorption after oral administration of poorly soluble drugs.
Simulations Plus to Participate in KeyBanc’s 25th Annual Technology Leadership Forum
Simulations Plus to Participate in KeyBanc’s 25th Annual Technology Leadership Forum
Cellulose ether and carbopol 971 based gastroretentive controlled release formulation design, optimization and physiologically based pharmacokinetic modeling of ondansetron hydrochloride minitablets
This study aims to design and optimize ondansetron (OND) gastro-retentive floating minitablets for better and prolonged control of postoperative nausea and vomiting (PONV) with improved patient compliance.
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Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval.
Simulations Plus Announces New Research Project with the International Collaboration on Cosmetics Safety
Objective to define best practices for the use of novel PBK modeling strategies to support animal-free safety assessment of new chemicals.
Key Takeaways on the Acceptability of PBPK from the ICH Harmonised Guideline on Drug Interaction Studies
One of the significant challenges faced by pharmaceutical companies is the sometimes unclear guidance on what data regulators want to see included in their submissions and the format in which it should be provided.
Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation
The development of generic ophthalmic drug products with complex formulations is challenging due to the complexity of the ocular system and a lack of sensitive testing to evaluate the interplay of its physiology with ophthalmic drugs.
Scientific Content Development
A client was anticipating a new FDA indication for their product that would allow it to be used as a first-line therapy.