Utilizing Pharmacokinetic and Pharmacodynamic Modeling & Simulation Technologies for Anesthesiology and Pain Medicine
Today, we are interviewing Professor Gyujeong Noh from Anesthesiology and Pain Medicine/Clinical Pharmacology and Therapeutics…
CertaraJune 17, 2022
Infographic- Project Optimus
What Oncology Drug Developers Should Expect from the FDA’s Project Optimus. With deep experience in…
CertaraJune 15, 2022
Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline
The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public…
CertaraJune 14, 2022
Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease
Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a…
CertaraJune 6, 2022
Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry
Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…
CertaraJune 3, 2022
PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA
In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…
CertaraJune 2, 2022
eCTD Submission Challenges
Industry standards are continually evolving, creating an environment of rapid change. With change comes challenges.…
CertaraJune 1, 2022
Leveraging Clinical Data from One Rare Disease to Support Drug Approval for Another
Atypical hemolytic uremic syndrome (aHUS) is an ultra-rare genetic disease that causes abnormal blood clot…
CertaraJune 1, 2022
PK Modeling Supports Dosing Strategy for Patients with Hepatic Impairment
Primary biliary cholangitis (PBC) is a chronic disease that impedes bile flow from the liver,…
CertaraMay 31, 2022
