How to Navigate the FDA Landscape for an Orphan Drug
Rare diseases are a public health priority. FDA has launched several programs and a final…
CertaraFebruary 21, 2024
Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials
A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…
CertaraDecember 19, 2023
FDA Trends for Accelerated Drug Approvals in Oncology Indications
The FDA has modified and increased expectations around data needed to support accelerated approvals in…
CertaraSeptember 20, 2023
Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities
Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…
CertaraSeptember 20, 2023
Artificial Intelligence: What is it & how can it accelerate rare disease drug development?
Large & complex information streams present opportunities for the AI data scientist to aid in…
CertaraFebruary 3, 2023
Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer
Bispecific antibodies are an emerging class of antibodies developed in recent years that provide new…
CertaraJanuary 23, 2023
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
