268 results

Certara’s Vaccine Simulator™ Accurately Predicted Optimal Timing Between Doses for COVID-19

Clinical Study Confirms Quantitative Systems Pharmacology (QSP) Prediction, Showcasing the Power of Biosimulation Technology Princeton, N.J., July 23, 2021: Certara, a global leader in biosimulation, today announced that its Vaccine Simulator accurately predicted that eight weeks was the optimal timing between the first and second dose of COVID-19 vaccines. The Pitch study conducted at Oxford … Continued


Small Molecules, Biologics, and Vaccines: Three Uniquely Divergent Roads to FDA CMC Approval

In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. … Continued


Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

Accelerate The Simcyp PBPK Simulator enables you to accelerate your clinical development by avoiding and/or replacing clinical trials with PBPK modeling. Quickly perform early PK first-in-human dose assessments to triage potential compounds with best chance of success. Test alternative formulations in silico with the Simcyp Simulator. Advise Advise clinical trial design to reduce the study … Continued


Development considerations for pioneering a NASH clinical program

The National Institute of Diabetes and Digestive and Kidney Diseases considers nonalcoholic fatty liver disease (NAFLD) as a condition wherein the liver stores excess fat and nonalcoholic steatohepatitis (NASH) as one type of NAFLD. Individuals with obesity and type 2 diabetes appear to be at greater risk of developing NAFLD. Many innovative and scientifically intriguing … Continued


New FDA Forms 356h and 1571

In August 2017, FDA updated both the Form FDA 356h (Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use) and the Form FDA 1571 (Investigational New Drug Application) to include new data fields. FDA asks that all sponsors begin using these new FDA forms 356h and 1571 immediately; however, it … Continued


Maximizing Oligonucleotide Therapeutic Development: How They Work

This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest in oligonucleotide therapies, which are composed of short strands of DNA or RNA, is growing rapidly; there are at least 135 of them currently in development.1 Underscoring their proliferation, a PubMed search for “oligonucleotide therapeutics” generated more than 35,000 hits. … Continued


Certara Releases New Versions of Its Preeminent Quantitative Systems Pharmacology (QSP) Simulators for Expediting Development of Biologics and Immuno-oncology Therapies

Expanded capabilities in company’s Immunogenicity and Immuno-oncology QSP Simulators broaden applicability for addressing safety and efficacy challenges PRINCETON, N.J., May 13, 2021 (GLOBE NEWSWIRE) — Certara, Inc. (Nasdaq: CERT), the global leader in biosimulation, today announced the launch of new versions of its Immunogenicity (IG) and Immuno-oncology (IO) Quantitative Systems Pharmacology (QSP) Simulators to help address … Continued


How to Avoid Validation Errors on Scanned FDA Forms

Not using electronic signatures to sign Forms FDA 356h or 1571? That’s okay, but you will need to know how to avoid validation errors on scanned FDA forms. The accepted practice is to include two copies of the form in your submission: An unsigned copy of the fillable form, to be used by FDA to … Continued

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