Therapeutic Specialties Archives

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

Publication

ScienceDirect: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial

Observational studies have postulated a therapeutic role of metformin in treating COVID-19. We conducted ...(cont.)

CertaraDecember 22, 2021

Blog

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

New therapeutics discovery and development for ocular diseases have been traditionally associated with a low…

CertaraDecember 15, 2021

Blog

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with…

CertaraNovember 5, 2021

Therapeutic Specialties

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

ScienceDirect: Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

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