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  • Cognigen Corporation - Pharma Of The Future
    simulation has to encompass 3 types of excellence strategic operational and technical READ MORE September 19 2012 Modeling as a framework for knowledge synthesis Cross functional interdisciplinary knowledge synthesis is lacking in many development programs READ MORE September 6 2012 Mind the gap Why do you need a gap analysis Because one thing is certain The sooner you find the gaps and fill them the better READ MORE May 25 2011 Innovation at the intersection of creativity and automation In the same way that the guillotine concentrates the senses the need to improve productivity in the pharmaceutical industry has become a life or death imperative READ MORE April 28 2011 Why don t computer systems help me as much as I think they should Complete and clear requirements are a critical element in the successful design and execution of workflows for pharmacometric analyses READ MORE April 14 2011 Scientific workflows the knowledge generating engines of R D The interdisciplinary collaboration needed to specify workflow requirements to achieve consensus on study methods and to detail how to interpret and present results is surely the most critical step for improving productivity in the Pharma of the Future READ MORE March 30 2011 Productivity is not a four letter word On that global stage called The Pharmaceutical Industry one of the dramas unfolding is the urgency to improve productivity at all levels industry team and individual READ MORE November 2 2010 You WILL innovate Innovation is something that comes from a mysterious creative force that strikes like lightning to the fortunate inventor or is it READ MORE September 15 2010 But my projects are special To be successful interdisciplinary R D needs a conceptual synthesis to bridge the disciplines and allow research results from one discipline to be applied to the questions of

    Original URL path: http://nonmem.org/index.php/cognigen/blog_pharma_of_the_future/P10 (2016-04-25)
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  • Cognigen Corporation - Pharma Of The Future
    Future The pharma industry has a critical need to establish model based drug development The Pharma of the Future PoF program is a research initiative to support this important enterprise transformation In this blog entry we tell the story of the program that inspired PoF READ MORE January 20 2010 Intro to Pharma of the Future The pharma industry has a critical need to establish model based drug development The Pharma of the Future PoF program is a research initiative to support this important enterprise transformation READ MORE November 17 2009 An Uncommon Vignette Tired of late stage development failures the CEO of a pharmaceutical company decides to act on the promise of pharmacometrics Fix it he says to the head of clinical pharmacology I don t care what it takes READ MORE October 27 2009 Square Pegs in Round Holes A crusading scientist identifies a potential public health threat and uses the internet to get access to a cache of data from several studies Sound like the plot of a new medical thriller READ MORE September 11 2009 Kerfuffle pt 3 A kerfuffle is the polite term for a cascading series of errors that can be initiated by a seemingly innocuous event that then leads to other errors that seem to gain in severity and impact Formalization of the pharmacometrics process and the definition of process maps for the key tasks invoked in modeling and simulation activities can prevent kerfuffles READ MORE February 17 2009 Kerfuffle pt 2 A kerfuffle is the polite term for a cascading series of errors that can be initiated by a seemingly innocuous event that then leads to other errors that seem to gain in severity and impact But where do kerfuffles come from and how do we prevent them from happening READ MORE

    Original URL path: http://nonmem.org/index.php/cognigen/blog_pharma_of_the_future/P20 (2016-04-25)
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  • Cognigen Corporation - Pharma Of The Future
    So we thought hey let s give him an outlet to share his wisdom And so the Cognigen blog was born Check back here often for insightful articles unique views on industry trends and a whole lot more on the evolution of this critical field November 7 2008 Kerfuffle pt 1 k r f f l to become disheveled A kerfuffle is the polite term for a cascading series of errors that can be initiated by a seemingly innocuous event that then leads to other errors that gain in severity and impact This essay describes a strategy for eradicating or minimizing the impact of kerfuffles in pharmacometrics READ MORE Page 4 of 4 pages First 2 3 4 Monday April 25 2016 Blog Archives 2016 2 April 1 March 1 2015 5 October 2 April 1 January 2 2014 1 October 1 2013 13 December 1 November 1 October 1 June 2 May 1 April 3 March 1 February 2 January 1 2012 13 December 2 October 2 September 4 March 1 February 2 January 2 2011 10 October 1 June 1 May 1 April 2 March 3 January 2 2010 20 December 1 November 2 September 3 August 3

    Original URL path: http://nonmem.org/index.php/cognigen/blog_pharma_of_the_future/P30 (2016-04-25)
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  • Cognigen Corporation - Blog Archive
    are only at the beginning of a new era of model driven R D A historical perspective from Alison Boeckmann One of the developers and programmers of NONMEM Reprinted here with Alison s permission READ MORE October 3 2015 Visualize in KIWI 1 5 Available Now New Features in KIWI 1 5 KIWI 1 5 continues to bring user experience to a new level through efficient decisive model building and co worker collaboration Visualize Visualize diagnostic plots and parameters for all candidate models in one view Formats Labels Fully customized formatting and labeling within KIWI Cross Project and Co Worker Graphical Profiles Share your share suite of customized diagnostic plots with your co worker or use them on your next project READ MORE October 3 2015 Conceptual Schemas The central focus of MBR D is not the mathematical equations but rather the conceptual synthesis process that integrates all available information and rational extrapolations to better understand drug pharmacology in the context of the disease process The outcome of this synthesis process is a conceptual schema a term borrowed from database design The schema represents a series of assertions about the nature of the disease process and drug pharmacology It describes the entities of significance to a research program their characteristics or attributes and the relationships between pairs of entities thought to be significant READ MORE April 25 2015 Run Record for Model Development The EMA and FDA recommend including a run record in your technical report to describe any major decisions and should include an overview of the steps taken during model development KIWI 1 3 available in May 2015 will reduce the time taken to perform this task to just minutes READ MORE January 18 2015 Rethinking Scientific Workflows While we now have access to adequate computing power for most applications we lack the tools required to properly manage the investigative process We need the tools to organize the results of the numerous model configurations sort through the results and compare alternative formations of the model in order to determine reasonable next steps and decide that a particular model or group of models is adequate for the task at hand And this is where the idea of workflow comes to the forefront READ MORE January 16 2015 Progressive reporting and model based drug development KIWI has been specifically designed to recognize the dynamic nature of the model building effort in an ongoing drug development program KIWI provides functionality to meet the scientists need for extensive documentation of the analysis pathway and collateral results management s need for summaries of modeling and simulation highlights and regulatory agencies need for transparency and reproducibility READ MORE October 12 2014 History of Pharma of the Future Pharmacometric modeling and simulation has moved from its infancy as a novel way of approaching the analysis of clinical pharmacokinetic data to become an invaluable tool in pharmaceutical and biotechnology research and development Early tentative applications of modeling have given way to robust model based drug development

    Original URL path: http://nonmem.org/index.php/cognigen/blog_archive/C5 (2016-04-25)
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  • Cognigen Corporation - Comments - data
    program to assist with formulation optimization as we believe there is an opportunity to leverage the large GastroPlus user base to drive further adoption of DDDPlus In addition to the enhancements in version 5 0 that we are announcing today we are already at work on further expanding the scope of DDDPlus simulations to include long acting injectable microspheres as part of one of our funded research collaboration agreements with the U S Food and Drug Administration About Simulations Plus Inc Simulations Plus Inc is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents Our software is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies and regulatory agencies worldwide Our innovations in integrating new and existing science in medicinal chemistry computational chemistry pharmaceutical science biology and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation For more information visit our website at http www simulations plus com Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 With the exception of historical information the matters discussed in this press release are forward looking statements that involve a number of risks and uncertainties Words like believe expect and anticipate mean that these are our best estimates as of this writing but that there can be no assurances that expected or anticipated results or events will actually take place so our actual future results could differ significantly from those statements Factors that could cause or contribute to such differences

    Original URL path: http://nonmem.org/index.php/comments/data (2016-04-25)
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  • Cognigen Corporation - Comments - data
    estimates is critical in decision making but it is often confusing opening different graphs at one time by cutting and pasting into a word document or powerpoint presentation In KIWI all the plots appear side by side in one view and with a click of a button the parameter and variance estimates for the same models appear The models can be easily switched up on the fly Your teams will love being able to more easily distinguish between models by reviewing graphs and parameter estimates simulataneously and having engaging discussions where decisions are made KIWI 1 5 has customized format and label collections that can be used throughout a project or across different projects This provides the modeler more control over the appearance of their graphs and tables And these high quality graphs can be downloaded individually or as a group for direct import into a presentation or regulatory document All formatted all validated Significantly reduces your time spent in preparing presentations and regulatory documents Profiles unique to KIWI is a user interface to generate customized diagnostic VPC or bootstrap graphs with the ability to stratify by covariate dose groups etc A modeler can create as many profiles as desired The Profiles can now be easily share across projects for a single user or shared with co workers saving considerable time Just what you would expect from a fully integrated modeling and communication platform We can t wait to tell you what will be coming with KIWI 1 7 and KIWI 2 0 Keep Tuned Learn more about KIWI here For KIWI licensing information or a KIWI demonstration call us at 1 716 633 3463 or send us a note You have chosen to email the article entitled Visualize in KIWI 1 5 Available Now Your Name Your Email Friends

    Original URL path: http://nonmem.org/index.php/kiwi/comments/data (2016-04-25)
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  • Cognigen Corporation - Forensic Pharmacometrics
    guide decision making In 2014 Cognigen worked on more than 40 development programs each with their own story Cognigen s experience and expertise can help you prepare for the highly visible stress inducing presentations to senior management or regulatory agencies Telling better stories can take several forms you might arrange the content so that it is more aligned with target audience needs you might add informative graphics that make difficult concepts more accessible or you might work to improve your presentation skills so that your presentations inspire confidence in the message you have to deliver Let Cognigen help you develop effective stories based on your work We will review your results and discuss your goals for upcoming presentations We will offer suggestions for content and the story narrative We will work with you to prepare for those critical presentations that can improve your likelihood of success View our Population PK PD and PBPK services You have chosen to email the article entitled Better Stories to Tell Using Modeling and Simulation Your email address Recipient s email address Separate multiple email addresses with commas Message Hey I think that you might want to check out this article that I just read on Cognigen s website http nonmem org index php pkpdsupport comments better stories to tell using modeling and simulation Because there s no such thing as immaculate communication don t ever stop talking about the system Losk 1989 Good Reads In Silico Prediction of Oral Bioavailability Pharmacokinetics and Exposure Response Relationships of Dasotraline in the Treatment of Attention Deficit Hyperactivity Disorder in Adults Toward Progressive Reporting of Modeling and Simulation Results Part 1 Analysis of KIWI Metadata Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function Population Pharmacokinetic Evaluation of Eslicarbazepine Acetate for

    Original URL path: http://nonmem.org/index.php/development_strategies/comments/better_stories_to_tell_using_modeling_and_simulation# (2016-04-25)
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  • Cognigen Corporation - Forensic Pharmacometrics
    about the disease process and drug effects This framework will support ongoing gap analyses that guide cost effective experimental investigation plans analytical strategies and disease drug models to address the gaps that are uncovered The pursuit of excellence is a strong tradition at Cognigen that is demonstrated in every interaction with our clients Scientific excellence asking the right question then designing and conducting a valid study that answers that question and influences future research is widely accepted as a benchmark for success in research However excellence of a more complicated sort is required to ensure the success of early drug development efforts In this setting there are at least three dimensions to excellence namely strategic excellence operational excellence and technical excellence Strategic excellence is demonstrated when knowledge about the disease and the drug are used to formulate study goals and objectives to specify decision criteria for near term reviews and to provide a rationale for proceeding with a development program Operational excellence is a result of careful study design precise data selection and definition and attention to detail in preparation of high quality error free experimental results and study reports Technical excellence results when scientists use their training and experience to identify cross disciplinary relationships in the data formulate and test hypotheses and accurately represent the data in management reviews Cognigen collaborates closely with each client to ensure excellence in every project We listen we ask questions and we offer our expertise Our deliverables reflect our commitment to the strategic technical and operational excellence of our work The greatest compliment that Cognigen can receive is when no questions arise from a careful review of our work by our clients or regulatory authorities Have a question about our Phase 1 Pharmacokinetic and Biomarker Services send us a note You have chosen

    Original URL path: http://nonmem.org/index.php/development_strategies/comments/phase_1_studies_the_pursuit_of_excellence_in_early_clinical_development# (2016-04-25)
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