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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/blog_archive (2016-04-25)
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  • Cognigen Corporation - ecpag
    of Pharmacometric Knowledge in Regulatory Review Application of Quantitative Tools Where is FDA Going Grasela Learning from Doing A Workshop on Pharmacometric Heuristics 2006 Scientific Meeting Presentations Ludden NONMEM VI New Features Michels The Use of Collinearity Diagnostics in PK Model Building Guzy The Monte Carlo Parametric Expectation Maximization Algorithm Sale Parallel NONMEM Initial experience Devarakonda Population Pharmacokinetics of Theophylline in South Indian Patients Heathman Incorporating Uncertainty and Variability into Various Types of Simulation Implementation and Application Cirincione The Role of Requirements in Model Based Decision Making Wang The Importance of Early Interaction with FDA EOP2A Experiences 2004 Workshop Presentations Session 1 Model Qualification Fiedler Kelly Introduction to Workshop Session I Content and Terms Gastonguay Brief Overview of Model Qualification and Validation Methodologies Case Study 1 PopPK Analysis of a High Dose Antineoplastic for Bone Marrow Transplant in Adults and Children Case Study 2 PopPK Analysis of an Intravenous Dose Ranging Study Evaluating an Antineoplastic Agent in Adults and Children Case Study 3 Drug X PK PD Modeling Simulation Case Study 4 Model Qualifications in Industrial Applications Duffull Selecting The Right Model Across Modeling Platforms ï ½ A Pop PK PD Perspective Session 2 Software Validation Mould Introduction to Workshop Session II Content and Terms Gobburu Population Analysis Software Validation Good Practices Fiedler Kelly Example Documentation of Population Software Validation Efforts 2004 Scientific Meeting Presentations Booth Population Pharmacokinetic Modeling and Simulation Derived Dosing of Intravenous Busulfan in Pediatric Patients Gopalakrishnon A Pharmacokinetic Pharmacodynamic Model for Insulin to Guide Optimal Drug Delivery Jadhav Mixed Effects Model Qualification Using Predictive Check Duan Population Pharmacokinetics in Assessing Drug Drug Interactions Consideration During Regulatory Review Guzy Application of the Monte Carlo Parametric Expectation Maximization MCPEM Algorithm for Analyzing Population Pharmacokinetic Pharmacodynamic PK PD Data Li Impact of Mis specified Residual Model on Parameter Estimates

    Original URL path: http://nonmem.org/index.php/ecpag (2016-04-25)
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  • Cognigen Corporation - Knocked My Socks Off
    Heffernan believes that the people inside those organizations were too afraid of conflict READ MORE May 23 2013 Get over it Vulnerability is the birthplace of innovation creativity and change says researcher Brené Brown in a 2012 TEDTalk READ MORE April 22 2013 How a tax begat bebop The end of The Swing Era and the beginning of bebop was a consequence of a tax intended for wealthy fans of the big band sound says Eric Felton READ MORE April 5 2013 14 million invisible Americans The federal government spends more money each year on cash payments for disabled former workers than it spends on food stamps and welfare combined READ MORE March 21 2013 Things to worry about The internet s insatiable demand for words creates global deflation in the value of words says David Gelernter This is something we should be worried about READ MORE January 7 2013 I don t understand why you don t agree with me An essay by Gary Gutting contains one of the clearest explanations of the differences between inductive and deductive reasoning I have seen READ MORE December 10 2012 Don t shoot What happens when police gangs and communities come together to address one of America s most intractable social problems This strategy truly knocked my socks off READ MORE October 1 2012 There s room for more than one genius Carole King s songwriting genius juxtaposed with the genius of talented singers was demonstrated in a recent interview READ MORE September 19 2012 Inventors and innovation Sometimes it is days and even months later that I am brought face to face with something that suggests the simple solution that I am looking for READ MORE Page 1 of 5 pages 1 2 3 Last Monday April 25 2016 Blog Archives

    Original URL path: http://nonmem.org/index.php/blog_knocked_my_socks_off (2016-04-25)
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  • Cognigen Corporation - Nonmem
    Apr 1995 This archive is maintained by Cognigen Corporation updates occur nightly If you experience any problems with the archive kindly let us know About NONMEM The NONMEM Project at the University of California San Francisco is concerned with the development of data analysis techniques and exportable software for fitting nonlinear mixed effects statistical regression type models These techniques are particularly useful when the data are population pharmacokinetic pharmacodynamic data and when there are only a few PK PD measurements from some individuals sampled from the population or when the regression design varies considerably between individuals However increasingly the techniques are also being used advantageously with better designed experimental type data About this Archive This archive contains past discussions queries which have been posted to the NONMEM Users Network The archive is organized into threads each identified by a subject line and sorted from most recent posting to most ancient Clicking on a particular subject line brings up a file which contains the originating message and all related replies in the order in which they were posted to the network If there is a particular subject or keyword which you are interested in a search engine can be accessed from the top of this page and it will search this entire site for you To enroll in the NONMEM Users Network You can request to be added to the NONMEM Users Network by sending an e mail message to nmusers request globomaxnm com After you have subscribed you can post to the newsgroup via this address nmusers globomaxnm com Monday April 25 2016 Harness the power of pharmacometrics Raise your hand if you wish there was a way to make drug development more efficient Guess what There is It s called model based drug development and it involves using quantitative

    Original URL path: http://nonmem.org/index.php/resources_nonmem (2016-04-25)
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  • Cognigen Corporation - Pharma Of The Future
    became the foundation for the KIWITM platform A variety of internally and externally focused training programs to advance the science and technology required for planning executing and reporting M S efforts Click here for more information about the PoF program READ MORE March 9 2016 A historical perspective from Alison Boeckmann Postscript All of us in the pharmacometrics community owe a debt of gratitude to Lewis Stuart Alison and the many others who were involved in the development of NONMEM The program has proven to be of tremendous value in dealing with the challenges we encounter in pharmaceutical research and development NONMEM has truly changed the landscape and really we 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 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 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 activities in which pharmacokinetic and pharmacodynamic modeling and simulation results are widely utilized to improve the probability of successful clinical trials Pharma of the Future Historical Time Line READ MORE November 22 2013 The inspiration of great architecture Get the habit of analysis analysis will in time enable synthesis to become your habit of mind Frank Lloyd Wright In Barnes Noble Book of Quotations by Robert I Fitzhenry 1987 READ MORE October 31 2013 Our move to new offices Extensive planning dedicated teamwork mad skills and a sense of humor result in a successful move to new digs for Cognigen READ MORE June 14 2013 Intelligent wondering investigative clinical pharmacology With the use of modeling explorations of the determinants of drug efficacy and safety are more thorough and the analyses provide solid support for dose recommendations and labeling content READ MORE April 9 2013 An omission a recommendation and a prediction A report from the President s Council of Advisors on Science and Technology gives recommendations that have the audacious goal of doubling over the next decade the rate of invention of new medicines for patients while increasing drug safety READ MORE February 19 2013 The

    Original URL path: http://nonmem.org/index.php/blog_pharma_of_the_future (2016-04-25)
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  • Cognigen Corporation - Contact US
    discuss Or a question you d like to ask Or a great recipe you d like to share Just fill out the form below or give us a call and we ll be more than happy to take a break from our modeling Cognigen 1780 Wehrle Drive Suite 110 Buffalo NY 14221 7000 Phone 1 716 633 3463 Fax 1 716 633 7404 Choose Recipients Contact Us Page First Name Last Name Your Email Subject Message Attach File Note The maximum file size is 128M Please enter the word you see in the image below Monday April 25 2016 Harness the power of pharmacometrics Raise your hand if you wish there was a way to make drug development more efficient Guess what There is It s called model based drug development and it involves using quantitative analysis to better design protocols determine dosage levels and figure out other neat stuff that lead to successful regulatory filings Once you see how incredible and cost effective pharmacometrics can be you ll be hooked News and Events Simulations Plus Releases DDDPlus Version 5 0 Poster presented at 2016 AAN Conference in Vancover BC Canada Visit us at the ASCPT Meeting in San Diego

    Original URL path: http://nonmem.org/index.php/contact_us (2016-04-25)
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  • Cognigen Corporation - Pharma Of The Future
    became the foundation for the KIWITM platform A variety of internally and externally focused training programs to advance the science and technology required for planning executing and reporting M S efforts Click here for more information about the PoF program READ MORE March 9 2016 A historical perspective from Alison Boeckmann Postscript All of us in the pharmacometrics community owe a debt of gratitude to Lewis Stuart Alison and the many others who were involved in the development of NONMEM The program has proven to be of tremendous value in dealing with the challenges we encounter in pharmaceutical research and development NONMEM has truly changed the landscape and really we 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 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 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 activities in which pharmacokinetic and pharmacodynamic modeling and simulation results are widely utilized to improve the probability of successful clinical trials Pharma of the Future Historical Time Line READ MORE November 22 2013 The inspiration of great architecture Get the habit of analysis analysis will in time enable synthesis to become your habit of mind Frank Lloyd Wright In Barnes Noble Book of Quotations by Robert I Fitzhenry 1987 READ MORE October 31 2013 Our move to new offices Extensive planning dedicated teamwork mad skills and a sense of humor result in a successful move to new digs for Cognigen READ MORE June 14 2013 Intelligent wondering investigative clinical pharmacology With the use of modeling explorations of the determinants of drug efficacy and safety are more thorough and the analyses provide solid support for dose recommendations and labeling content READ MORE April 9 2013 An omission a recommendation and a prediction A report from the President s Council of Advisors on Science and Technology gives recommendations that have the audacious goal of doubling over the next decade the rate of invention of new medicines for patients while increasing drug safety READ MORE February 19 2013 The

    Original URL path: http://nonmem.org/index.php/cognigen/blog_pharma_of_the_future (2016-04-25)
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  • Cognigen Corporation - Comments - global_health_initiative
    eradicate malaria The goal of the Global Health initiative is to reduce the risks and cost of antimalarial drug development and speed the delivery of new life saving medicines This goal will be pursued via two interrelated activities The first is to deploy a technology infrastructure incorporated into the KIWI platform that will remove the barriers to communication amongst team members and provide the processing power and organizational tools required to support complex modeling and simulation activities The second is to harness the extensive knowledge of team scientists to create a comprehensive model of the lifecycle of the malaria parasite and the pharmacology of potential new drugs This disease drug model will be used to guide the design analysis and interpretation of clinical trials enhance the regulatory review process and eventually optimize the clinical use of new medicines for malaria Why this initiative Scientists relish the challenge of puzzling over difficult problems but effectively dealing with some of the world s most intractable problems such as the eradication of malaria will require the ideas and insights that emerge when scientists from different disciplines collaborate as a team Ultimately by fostering interdisciplinary collaboration and effective decision making the Global Health initiative opens up new frontiers in the effort to meet societal needs for innovative cost effective therapies Building a comprehensive disease drug model for malaria A comprehensive disease drug model for malaria will be developed by knitting together existing pharmacokinetic and pharmacodynamic models with an understanding of the biology of the disease and the mechanism of action of potential new medicines The team will develop a conceptual schema to serve as a blueprint for establishing a systems pharmacology model which can be challenged with data arising from a variety of sources including in vitro experiments in vivo preclinical experiments utilizing the

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