Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and rising costs. Each step of drug development must therefore be as accurate and efficient as possible. In the preclinical phase, the study of pharmacokinetics (PK) and pharmacodynamics (PD) of a new drug plays a crucial role. Regulatory agencies will not approve a drug submission with insufficient or non-compliant PK/PD analysis. As the gold standard for Noncompartmental Analysis (NCA), Certara’s Phoenix WinNonlin software also allows scientists to assess bioequivalence, and to perform PK/PD modeling and simulation, including the development of custom models via a flexible and intuitive graphical model builder. The user-friendly PK/PD modeling software can maximize the capabilities of pharmacokineticists, toxicologists, drug metabolism and pharmacokinetic (DMPK) scientists, and clinical pharmacologists. In this blog post, we summarize the top 5 reasons why experts choose Phoenix WinNonlin as their preferred software for NCA and PK/PD modeling in studies ranging from preclinical and toxicokinetic (TK) studies to clinical and first in human studies.
1. Widely Used and Respected
More than 6,500 researchers at 1,500 pharmaceutical companies and academic institutions worldwide rely on Phoenix WinNonlin. Indeed, 100% of leading pharma companies as surveyed and published in the January 2015 IQ Consortia report on preclinical PK/PD modeling rely on Certara’s software. In addition, Phoenix has a strong reputation in academia. This is reflected in the approximately 15,000 publication and academic references to the use of WinNonlin using Google Scholar – far more than any competing software.
2. Extensively Utilized by Regulators
Part of the reason Phoenix WinNonlin is considered the industry gold standard software for PK/PD and NCA analysis is because of Certara’s relationships with regulatory agencies such as the US (United States) FDA (Food and Drug Administration), EMA (European Medicines Agency), and Japan PMDA (Pharmaceutical and Medical Devices Agency). The FDA alone is using more than 250 licenses across six of its centers, including drugs, biologics, and generics. Certara provides these agencies with WinNonlin, onsite training courses, and opportunities for FDA and others to have direct input about the features added to future releases of the product. This means that any regulatory submissions that include WinNonlin results can be easily received and processed by the FDA and other regulatory agencies.
3. Automated and Reliable
Using Phoenix WinNonlin saves time, money, and resources in the drug development process. The software automates workflows for PK/PD analyses and enables improved processes between research teams. Scientists report efficiency gains of 50% or more by using templates and wizards that allow them to create PK/PD analyses in an intuitive workflow schema that can be copied, reused, and shared with colleagues. Workflow templates are available and can be customized to meet researcher’s needs, using WinNonlin to import raw data and perform exploratory analysis, plotting, NCA, and PK/PD modeling, all the way through to tabulation and reporting of results. All work is mapped into a visual workflow engine that leads to more efficient project management, changes, and error detection.
4. Collaboration is Easy
Many smart features make collaboration in Phoenix WinNonlin as easy as possible. Users can conveniently store input files, models, workflows, tables, charts, analyses, output, email, and Word documents (e.g., the protocol) in a single project file. The project file can be sent to another researcher, QA (Quality Assurance) staff or a regulatory agency for easy re-analysis. Most important, dispersed teams can collaborate, building upon each other’s work within Phoenix. This means that the experts no longer must deal with lengthy project issues and can better focus on their PK/PD research.
5. Easily Validated
Regulatory guidelines require computer systems used in the pharmaceutical industry to be validated to assure proper performance. Phoenix WinNonlin is easily validated to comply with these guidelines. In fact, Certara can provide a Validation Suite application that has a set of detailed validation test scripts to streamline the process from months to days, providing assurance of regulatory compliance. In addition to the test scripts, the Validation Suite provides templates for validation deliverables such as the Requirements Specification, Validation Plan, Test Plan, and Traceability Matrix documents.
Our dedicated team of pharmacometricians and developers is working hard to build on Phoenix WinNonlin’s 30-year proven track record of success. Additional features that accelerate PK/PD modeling are coming! Want to learn more about Phoenix WinNonlin? Our experts look forward to exploring how the industry-leading PK/PD software can be a perfect fit for your organization.