Therapeutic Specialties Archives

Blog

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

Case Study

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

Conference

ACCP Annual Meeting

– – Booth

CertaraJuly 15, 2022

Case Study

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

Case Study

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

Case Study

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

Case Study

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…

CertaraApril 11, 2022

Blog

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…

CertaraFebruary 2, 2022

On-Demand Webinar

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This…

CertaraJanuary 13, 2022

On-Demand Webinar

PBPK Modeling of Antibody-Drug Conjugates – Concept and Application

Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a…

CertaraJanuary 13, 2022

Therapeutic Specialties

Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer

ACCP Annual Meeting

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

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

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

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus

PBPK Modeling of Antibody-Drug Conjugates – Concept and Application

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