Therapeutic Specialties Archives

Poster

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

Poster

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

Conference

American College of Toxicology 2025 Annual Meeting

– – Booth

CertaraMay 24, 2023

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

Therapeutic Specialties

FDA Trends for Accelerated Drug Approvals in Oncology Indications

Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities

American College of Toxicology 2025 Annual Meeting

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

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