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Phoenix WinNonlin 8.0: Updated NCA Engine and New Validation Suite

Phoenix WinNonlin 8.0 takes non-compartmental analysis (NCA) to a new level by adding many new features to minimize post-processing work and increase transparency with analysis. Additionally, a new validation suite is embedded within the Phoenix 8.0 application and provides an affordable, turnkey process that is significantly faster than other validation options.

Solution: PK/PD Modeling & Simulation
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Investigational Drug Gap Analysis

As the process of drug development has increased in cost and complexity, Certara has developed a service offering to assess a sponsors’ development program across multiple domains, and to craft a strategy to address each.

Solution: Clinical Pharmacology Strategy
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Simcyp Consultancy: Bespoke PBPK Modeling and Simulation

Physiologically-based Pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry, and genetics. We integrate this information with in vitro drug absorption, metabolism, and transport data to simulate and predict in vivo pharmacokinetics in virtual patient populations.

Solution: PBPK Modeling & Simulation
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Certara Nurture

Recognizing the great importance of serving pediatrics balanced against the inherent hurdles, Certara Nurture offers comprehensive pediatric drug development services.

Solution: Biosimulation, Drug Development & Regulatory Strategy, PBPK Modeling & Simulation, Regulatory & Medical Writing
Therapeutic Area: Pediatrics
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Burstable Compute Grid

Certara’s Compute Grid allows you to access up to 1,800 cores in the cloud with just one click, significantly accelerating model runs. Projects that took days can now be completed in hours or even minutes, affordably and without IT support.

Solution: PBPK Modeling & Simulation
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Quantify Osteoarthritis Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for osteoarthritis pain. The current version of the database includes information on all systemic pharmacological interventions. This includes mono and combination therapy with NSAIDs, acetaminophen, opioids, COX-2 inhibitors, norepinephrine reuptake inhibitors, anti-NGF, anti-epileptic drugs (AEDs), antidepressants, and muscle relaxants.

Solution: PK/PD Modeling & Simulation
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Quantify OS Clinical Outcomes Database

The Quantify Thrombosis in Orthopedic Surgery (TOS) Clinical Outcomes Database contains bleeding and VTE endpoint data from clinical trials investigating pharmaceutical interventions for preventing peri-operative thrombosis after orthopedic surgery of hip, knee, or both.

Solution: PK/PD Modeling & Simulation
Therapeutic Area: Oncology/Hematology
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Quantify HBV Clinical Outcomes Database

The Quantify HBV Database is developed to document clinical safety and efficacy information on different nucleosides (eg, entecavir, lamivudine, tenofovir disoproxil fumarate, telbivudine, adefovir and combination) focusing on 3 different endpoints: HBV DNA time course, HBsAG time course, and HBeAG seroconversion that are available in the public domain.

Solution: PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease
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