The Model-informed Precision Dosing Revolution Is Coming Blog Post
Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches are essential to realize the goal of precision dosing—providing the...
Obeticholic Acid—From PK Model to Drug Label On-Demand Webinar
Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By watching this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.
How AI Tech Is Changing Regulatory Writing Blog Post
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine...
Using Pharmacokinetics to Assure Chemical Food Safety Blog Post
As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and milk). Therefore, tissue residues are a unique concern in veterinary...
Best Practices in Clinical Pharmacology Gap Analysis Blog Post
September 19, 2025 Submitting your New Drug Application (NDA) to the FDA is the ultimate test of a drug program. Do you have answers to the agency’s 40 questions about your clinical pharmacology data package for an NDA submission? If...
