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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

5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses

Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and…

CertaraMarch 25, 2022

Fact Sheet

SEND Explorer – Product Family

Discover how SEND Explorer transforms nonclinical data analysis.

CertaraMarch 23, 2022

On-Demand Webinar

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…

CertaraMarch 22, 2022

Video

The Value of BaseCase

CertaraMarch 21, 2022

Announcement

Certara Selected by the European Medicines Agency to Provide Real World Solutions for Critical Regulatory Decisions

Princeton, N.J., March 17, 2022 -- Certara, Inc. today announced a four-year, framework service contract…

CertaraMarch 17, 2022

Blog

How to Fix Your Biggest Bioequivalence Mistakes

Bioequivalence is a commonly misunderstood term within biopharmaceutics. For starters, bioequivalence is a technical term…

CertaraMarch 16, 2022

Conference

ASCPT 2025 Annual Meeting

May 28-31, 2025 - Washington, DC

CertaraMarch 7, 2022

Blog

New PMDA Validation Rules 3.0 Explained

In this blog, we explore what you need to know about the update to the…

CertaraMarch 2, 2022

Blog

Experts Unravel the Top 5 Myths Related to Bioequivalence

Bioequivalence enables bridging safety and effectiveness of oral pharmaceutical dosage forms using pharmacokinetics. The concepts…

CertaraFebruary 18, 2022

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

5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses

SEND Explorer – Product Family

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

The Value of BaseCase

Certara Selected by the European Medicines Agency to Provide Real World Solutions for Critical Regulatory Decisions

How to Fix Your Biggest Bioequivalence Mistakes

ASCPT 2025 Annual Meeting

New PMDA Validation Rules 3.0 Explained

Experts Unravel the Top 5 Myths Related to Bioequivalence

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