Oncology/Hematology Archives

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

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

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

Blog

Accelerating ADCs’ development pipeline using Simcyp PBPK

With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…

CertaraOctober 15, 2021

Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

CertaraAugust 12, 2021

Case Study

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…

CertaraJuly 29, 2021

Blog

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…

CertaraJuly 8, 2021

Oncology/Hematology

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

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

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

Accelerating ADCs’ development pipeline using Simcyp PBPK

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success

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