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Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs Blog Post

The FDA-ASCO (American Society of Clinical Oncology) workshop on oncology dose optimization (3-5 May 2022) provided the most in-depth view to date into the FDA’s thinking regarding the Oncology Center…

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development Blog Post

2022 is shaping up to be the “year of the guidance” as the FDA has just released a new guidance on using circulating tumor DNA in early clinical drug development….

Simcyp Discovery Page

Innovative PBPK software that supports screening, first-in-human dose prediction, early DDI and formulation decisions.

Utilizing Pharmacokinetic and Pharmacodynamic Modeling & Simulation Technologies for Anesthesiology and Pain Medicine Blog Post

Today, we are interviewing Professor Gyujeong Noh from Anesthesiology and Pain Medicine/Clinical Pharmacology and Therapeutics at University of Ulsan College of Medicine, Asan Medical Center, South Korea to shed a…

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline Blog Post

The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public consultation phase. This guideline has several objectives. While aiming to harmonize methodologies and approaches for…

Diurnal

Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease Blog Post

Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a variety of generic glucocorticoid steroids (including hydrocortisone, dexamethasone, prednisolone, and prednisone in the US) with...

Advaxis Immunotherapies

Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry Blog Post

Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a technology platform which uses engineered Listeria monocytogenes. The company is headquartered in Monmouth Junction, New...

Genentech

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA Blog Post

In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to treat SMA in patients ≥2 months old, followed by the European Medicine Agency. Risdiplam addresses...

Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another Blog Post

Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot formation in small blood vessels throughout the body leading to kidney failure, other organ damage,...

First-in-Human (FIH) Dose Prediction Page

Streamline first-in-human studies with physiologically based modeling to optimize dosing and reduce trial risks.

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