Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development. The FDA has increased its use of Certara’s Phoenix software platform to nearly 400 users, which includes Phoenix WinNonlin®, non-linear mixed effects (NLME™), in vivo-in vitro (IVIVC.
A global provider of model-informed drug development and regulatory science, announced the launch of Phoenix 8.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD) and toxicokinetic (TK) modeling and simulation.
Included in this Phoenix rollout are Phoenix WinNonlin 8.0, Phoenix NLME 8.0, Phoenix Validation Suite 8.0 and Phoenix in vitro-in vivo correlation (IVIVC) Toolkit 8.0. Phoenix is used by 6,000 researchers at 1,500 biopharmaceutical companies and academic institutions in 60 countries. Phoenix is also employed by many global regulatory agencies for submittal review, including 11 divisions of the FDA. “Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs.
This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials,” said US FDA Commissioner Scott Gottlieb, M.D. “Phoenix is considered the gold standard in PK/PD modeling and simulation, and we take our responsibility to deliver continuous improvement and innovation very seriously. It has been only 12 months since the last Phoenix release, and we have added several important new features to the software to allow key drug development decisions to be made quicker,” said David Munro, President of Phoenix Technologies at Certara. Phoenix NLME 8.0 takes advantage of grid computing in several ways. It supports between model parallelizing, allowing two models to be run together on different processors.
It also permits within model parallel action so the analysis work for one model can be divided between several CPUs. Scientists can now use computation grids with hundreds of processors to get their analysis done in a fraction of the time. Phoenix can also combine the two approaches, enabling models to be run in parallel and on multiple cores, reducing model run time by 80-90%. This allows modelers to complete their analysis and scientific exploration in real time. They can then revise their hypothesis if necessary and move onto the next step. Phoenix NLME 8.0 also includes a distributed delay function to model delayed outcomes in therapeutic areas such as oncology, diabetes and arthritis.
This simplifies coding delays in PK/PD models and can be used in place of transit compartments, dual absorption models, effect compartment models, and indirect response models. This function is unique in its ability to automate these complex analyses.
Phoenix WinNonlin 8.0 includes several non-compartmental analysis (NCA) advances that were made in response to our ‘Voice of Customer’ analysis, which included valuable input from users all over the world. The NCA engine now automatically calculates more than a dozen new additional parameters for plasma and urine.
By cutting post-processing activities, this update can decrease analysis time by about 25%. Scientists can also define their own NCA parameters such as compute concentrations at any time point. In addition, scientists can set strict criteria for the terminal slope calculation in NCA to ensure compliance with their organization’s policies and procedures. This approach can also assist regulators by clearly stating what process and acceptability criteria were used. For the first time, the Phoenix WinNonlin Validation Suite is included within the Phoenix software.
Now validation can be completed in less than 30 minutes. Previous iterations took up to two days to execute. Furthermore, Phoenix WinNonlin Validation Suite 8.0 can be run in the background, allowing scientists to continue using other programs on their computer. Lastly, Phoenix validation results are now date stamped and stored on the scientist’s computer, providing easy access if a validation needs to be re-run. The Phoenix application has many settings for each object, making it time consuming to replicate a plot or table. Scientists can now save all their object settings for use later or apply them to the existing object with one click.
This ensures high quality output with less time and effort. Scientists can also lock workflows in Phoenix 8.0 Workbench.
Therefore, they can be confident that their settings haven’t changed without the painstaking quality control process that used to be required.
PRINCETON, N.J.-(BUSINESS WIRE)- FDA employs Certara Phoenix®, Simcyp® and Synchrogenix GlobalSubmit software platforms to efficiently assess and evaluate sponsor submissions data Certara®, the global leader in model-informed drug development, regulatory science, market access and real-world evidence solutions, today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications. The FDA has renewed its use of Synchrogenix’s electronic Common Technical Document (eCTD) review software, GlobalSubmit REVIEW™, providing enterprise-wide use at both the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) divisions. Synchrogenix is Certara’s regulatory science division. The FDA has stated that “it is aggressively moving towards an electronic regulatory submission to streamline the regulatory review process.” GlobalSubmit REVIEW is being used by the FDA to review New Drug Application (NDA), Biological License Application (BLA), Abbreviated New Drug Application (ANDA), Investigational New Drug (IND), Drug Master File (DMF), Annual Period Safety Report, and Advertising and Promotional Labeling submissions following the eCTD standard. The FDA also uses GlobalSubmit VALIDATE™ to process and validate eCTD submissions.
The agency selected GlobalSubmit in 2005 when it began its eCTD initiative. The FDA has increased its use of Certara’s Phoenix software platform to nearly 400 users, which includes Phoenix WinNonlin®, non-linear mixed effects (NLME™), in vivo-in vitro (IVIVC), Connect, Trial Simulator™ and training. Certara’s relationship with the FDA dates back to 2001, when its previously named Pharsight division formed a Cooperative Research and Development Agreement (CRADA) with the agency’s CDER division. Today, nine offices within the FDA use Certara’s Phoenix pharmacometrics software for internal research and to independently analyze, verify and complete the review of sponsor IND, BLA, NDA, ANDA and other submissions.
The FDA has also renewed its licenses for Certara’s physiologically-based pharmacokinetic (PBPK) Simcyp Population-based, Pediatric, Animal, and Cardiac Safety Simulators. The agency, which has been an associate member of the Simcyp Consortium since its inception in 2001, also uses Simcyp software to independently analyze and verify the review of sponsor IND, BLA, NDA, ANDA and other submissions.
Additionally, the FDA has awarded several grants to Simcyp and has renewed its CRADA with the company to create canine models to help streamline veterinary drug development and evaluation. “We are proud of our long history of partnering with the FDA to optimize the drug development and regulatory review processes,” said Certara CEO Dr. Edmundo Muniz. “The FDA Commissioner has been an outspoken advocate for the use of innovation, and electronic technologies to advance the delivery of safer, more effective medicines for patients. For example, Dr. Gottlieb recently stated: ‘I want to highlight one example of these steps, which we’re investing in, and will be expanding on, as part of our broader innovation initiative. It’s the use of in silico tools for improving drug development and making regulation more efficient.’ Certara continues to support this approach by providing ongoing education, training and collaboration initiatives for the industry.” About Certara’s Software Technology.
Phoenix is the most advanced and widely-used validated software for pharmacokinetics (PK), pharmacodynamics (PD) and toxicokinetic (TK) modeling and simulation worldwide. Sponsors use Phoenix extensively to perform data analyses for their new drug and biologics applications – 90-95% of novel drugs approved by the FDA are from companies that leverage Phoenix in their R&D programs. Trial Simulator, for example, is a powerful technology for evaluating clinical study design attributes and conducting statistical and sensitivity analyses likely to impact the trial’s success. GlobalSubmit REVIEW facilitates the regulatory review process by providing both the sponsor company and the FDA with an identical vantage point, ensuring that each regulatory activity can be filed and viewed according to regulations.
GlobalSubmit VALIDATE is used exclusively by the FDA to assess the technical validation criteria of all eCTD submissions passing through its Electronic Submissions Gateway (ESG), confirming compliance standards are met. Certara’s Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions and PK outcomes in various healthy and patient populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function. The aforementioned contract awards are HHSF63A, HHSF40A, and HHSF79P. About Certara Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration.
As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit. View source version on businesswire.com. Zacks Wall Street expects a year-over-year decline in earnings on lower revenues when Orion Energy Systems (OESX) reports results for the quarter ended December 2018.
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While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on February 6, 2019, might help the stock move higher if these key numbers are better than expectations. MarketWatch Of course, we have all benefited throughout the years by not having to pay taxes on contributions paid into our traditional 401(k) plans and IRA accounts and on the investment returns on those contributions. A little algebra reveals that the benefit is equal to exempting investment returns on plan assets from taxation. The group under consideration is working households ages 55-64 with assets in a 401(k) plan in 2016 — the most recent year for the Federal Reserve's Survey of Consumer Finances. Simply Wall St.
Yangtze Optical Fibre And Cable Joint Stock Limited Company (HKG:6869), which is in the communications business, and is based in China, saw a significant share price rise of over 20% in the past couple of months on the SEHK. As a mid-cap stock with high coverage by analysts, you could assume any recent changes in the company's outlook is already priced into the stock. Today I will analyse the most recent data on Yangtze Optical Fibre And Cable Limited's outlook and valuation to see if the opportunity still exists. Zacks Cummins (CMI) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2018. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on February 6. Thomson Reuters StreetEvents We do think that 2019 will be another strong year with earnings performance among the best in Nucor's history.
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