Updates fiscal 2025 revenue guidance range
Third quarter fiscal 2025 full results to be released on July 2, 2025, with conference call at 5 p.m. ET
Updates fiscal 2025 revenue guidance range
Third quarter fiscal 2025 full results to be released on July 2, 2025, with conference call at 5 p.m. ET
Synthetic opioids are linked to >90 % of opioid overdose deaths in the United States.
This work presents the solid-state evaluation of a new polymorph (Form M) discovered during the early-stage pharmaceutical development of a new chemical entity GDC-6599.
The aim of the present study was to assess the accuracy of the PBPK model in predicting the pharmacokinetic behavior of weakly acidic BCS class II drugs in humans through a multipronged approach of in vitro dissolution, in vivo studies, and in silico simulations.
Structure activity relationship (SAR) based read across uses existing toxicity data from an analog to predict the toxicity of a target chemical.
SHEN211 is a selective 3-chymotrypsin-like protease inhibitor that can protect against severe acute respiratory syndrome coronavirus 2.
As a monocyclic β-lactam antibiotic, aztreonam has regained attention recently because combining it with β-lactamase inhibitors helps fight drug-resistant bacteria.
Proven algorithms. Premium data. Predictions you can rely on.
As every researcher in early development knows, there is constant pressure to identify high-quality drug candidates—while also increasing the speed and efficiency of the discovery process.
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug.
The Complexity of Chemical Space
In this webinar, Dr. Brad Stefanovic, VP, Head of Clinical Innovation at Simulations Plus, discusses how biotechs and big pharma alike can stretch their clinical trials dollars while optimizing key areas for compliance and success.
Objective 1: Extend the linear model to nonlinear and delayed-effect models
Objectiv 2: Automation of data preparation, model selection, and reporting
Develop an R package for design evaluation which can use Monolix or Simulx projects as input
Modern drug development, which can take up to 15 years and cost as much as $11 billion USD, relies heavily on high-quality data.
Modern drug development, which can take up to 15 years and cost as much as $11 billion USD, relies heavily on high-quality data1. Recognizing the criticality of attaining quality data that is easily convertible to analysis-ready datasets, a survey was developed to obtain baseline information on data quality and data standards, largely from a CRO perspective.
Limited information is available about the transfer of articaine into breast milk and the associated risks to breastfed infants.
Non-small cell lung cancer (NSCLC) is a major cause of mortality in the United States[1].
While biologics offer promise in addressing a range of unmet medical needs, clinically observed BILI events are concerning for drug developers, health care providers and patients.
This report summarizes the proceedings of Session 2 of the two-day public workshop titled “Considerations and Potential Regulatory Applications for a Model Master File” hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on May 2–3, 2024.