PK/TK Services

Pre-clinical Pharmacokinetic/Toxicokinetic NCA Services Navigating pre-clinical regulatory safety assessments for drug candidate selection is a crucial step in the drug discovery and development process that requires extensive PK and TK expertise. Certara’s comprehensive PK/TK services offering integrates proven and extensive pre-clinical expertise with advanced modeling and simulation approaches using Phoenix WinNonlin®, the trusted industry standard […]

Read More
Topics:

Optimizing the Timing of Maternal Influenza Vaccination

Infants face a gap in protection against influenza between birth and the time of vaccination. Thus, maternal immunization is the only way to prevent flu infection in pregnant women and newborns. Our current understanding of the optimal timing of vaccination is rudimentary. Watch this webinar with Dr. Michael Dodds to learn how modeling and simulation (M&S) offers an alternate approach to dedicated clinical studies to determine the best time to vaccine pregnant women against influenza.

Read More
Topics:

How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

Julie Bullock

Many companies have tried and true clinical pharmacology practices. But when the rubber hits the road for your drug program, will these practices support regulatory success? Has your historic approach to drug development been updated to include the latest modeling and simulation innovations? It’s hard to change how you’ve historically done things. But, do you […]

Read More
Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

How Clinical Pharmacology Gap Analysis Can Create Value

Julie Bullock

During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only […]

Read More
Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

Using Model-based Meta-analysis to Inform Drug Development for Autoimmune Diseases

MBMA helps sponsors design less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio. Watch this webinar with Dr. Mark Lovern, Vice President at Certara Strategic Consulting, to learn how leveraging public data can provide value by abbreviating the “cash spiral” inherent to proprietary data.

Read More
Topics:

Using Model-informed Drug Development Approaches to Accelerate Orphan Drug Development

Maria Saluta

Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders […]

Read More
Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Learn More LinkedIn Twitter Facebook Email Subscribe to the Blog