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  • Cognigen Corporation - Forensic Pharmacometrics
    inform and 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 Knowing a failure has occurred is more important than the actual failure Kjos 1988 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 Adjunctive Therapy in

    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
    hypotheses 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

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  • Cognigen Corporation - Comments - better_understand_the_physiology_behind_your_compounds
    use that information to guide population PK and PD modeling and simulation efforts We can predict drug behavior in pediatric patient populations and perform clinical trial simulations to ensure patient safety and optimize efficacy outcomes in clinical trials while minimizing number of subjects needed We can perform PBPK modeling of preclinical data to define dosing strategies for First in Human FIH studies Other examples of the ways our PBPK modeling simulation scientists can assist with your research include in silico screening of compound libraries based on PK endpoints F Cmax AUC extrapolation of in vitro metabolism and transport data to in vivo values IVIVE and predicting exposures in animals and humans generation of mechanistic in vitro in vivo correlations IVIVCs for new formulation development preclinical formulation assessment clinical formulation development and implementation of Quality by Design QbD population pharmacokinetic and pharmacodynamic predictions for different disease states and age groups conduct virtual bioequivalence BE trials to optimize study design prediction of food effects positive and negative and implications for clinical treatment scenarios prediction of drug drug interactions DDI performance of nonlinear kinetic modeling for metabolism and carrier mediated transport prediction of tissue concentrations at the proposed site of action of a new drug optimization of generic formulation designs All major regulatory agencies around the world including the U S Canada Europe China and Japan have licenses to GastroPlus with reviewers in all divisions trained on the program Our interactions with them have helped us create report templates that present the methods and results in a clear concise manner Our reputation and credibility at regulatory agencies has led our clients to deploy GastroPlus as an integral component of drug evaluation prior to regulatory interactions and submissions For more information send us a note You have chosen to email the article entitled Better

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  • Cognigen Corporation - Comments
    PC PP DM EX their respective supplemental domains and ADaM basic data structures such as ADPC and ADPP Cognigen stays current with all data standards and is also involved with developing new CDISC data standards Susanne Sardella Associate Director of Data Management at Cognigen is a member of the CDISC ADaM PK Standards Development team According to Sardella Currently SDTM standards exist for the derived pharmacokinetic parameter PP results but there is no standard for the noncompartmental analysis dataset that the parameters are based on The goal of the ADaM PK development team is to provide a basic data structure for these analysis datasets that facilitates common statistical analysis methods and allows for the necessary traceability and transparency between other SDTM input data and noncompartmental analysis Cognigen takes pride in its comprehensive preparation and efficient process for converting data to CDISC standards Policies and procedures are in place to ensure quality of deliverables and the data programmers have a toolkit full of macros templates and snippets to facilitate the conversion time and ensure the validation of the results We would be happy to speak with you in more detail about our CDISC Services call us at 1 716 633 3463 or Send us a note You have chosen to email the article entitled CDISC Data Assembly Services Your Name Your Email Friends Name Friends Email Comments 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 cdisc data assembly services Please enter the word you see in the image below Required Field The choice between architectures may well depend upon which set of drawbacks the client can handle best Mark Maier and Eberhardt Rechtin 1997 Good Reads In Silico Prediction of Oral Bioavailability

    Original URL path: http://nonmem.org/index.php/pkpdsupport/comments/cdisc_data_assembly_services (2016-04-25)
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  • Cognigen Corporation - Comments
    modeling Throughout the project we remain in constant contact with you and your team We also use multiple tools to foster communication between scientists and data programmers Why choose Cognigen to create your analysis ready datasets for population analyses Our experience is unique and extensive Our preparation is comprehensive Our process is efficient Our communications are secure and to the point Our quality is assured Our reputation is hard earned There s safety in our numbers Our teams have strict policies and procedures in place to serve as unblinded data reviewers and frequently perform critical data programming tasks and analyses during the execution of blinded trials so that data and modeling results are available for top line results We would be happy to speak with you in more detail about our Data Assembly and Programming Services call us at 1 716 633 3463 or send us a note Resources SAS Community Wiki page The R Project for Statistical Computing S Products DIA Annual Meeting Clinical Data Management Track Society for Clinical Data Management CDISC Standards Cognigen can be Your Dedicated Programming Group You have chosen to email the article entitled Data Assembly and Programming Your Name Your Email Friends Name Friends Email Comments 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 data assembly and programming Please enter the word you see in the image below Required Field Given a change if the anticipated actions don t occur then there is probably an invisible barrier to be identified and overcome Susan Ruth 1993 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

    Original URL path: http://nonmem.org/index.php/pkpdsupport/comments/data_assembly_and_programming (2016-04-25)
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  • Cognigen Corporation - Comments
    of your dataset by Cognigen will ensure the dataset was built correctly that is valid and appropriate assumptions were applied and no critical errors were made in the processing and pooling of study data In addition a forensic assessment can determine the adequacy of the data for the analyses Cognigen can perform nonprogrammatic data checks such as requirements management code review program verification and comparison to raw data Cognigen can also perform programmatic data quality checks to detect potential outliers to verify record counts and listings against expectations to confirm accuracy and to generate and review graphical displays that will assist in determining if errors were made in the manipulation of the data Pharmacometric Technical Reports Well written and concise technical reports can make your submission stand out with the regulators Cognigen has developed canonical report templates to promote inclusion of content recommended in regulatory guidances Forensic assessment of your submission by Cognigen can ensure that your technical reports include these common omissions influence of study dropouts description of planned exploratory data analyses rationale for selecting covariates and for deciding which covariates were evaluated on which parameters and methods for calculating derived variables Why choose Cognigen to review your submission package Our experience is unique and extensive Our preparation is comprehensive Our process is efficient Our communications are secure and to the point Our quality is assured Our reputation is hard earned Our forensic review will arm you with knowledge credibility and confidence We would be happy to speak with you in more detail about our Forensic Pharmacometric Services call us at 1 716 633 3463 or send us a note Resources You have chosen to email the article entitled Forensic Pharmacometrics Your Name Your Email Friends Name Friends Email Comments Hey I think that you might want to check

    Original URL path: http://nonmem.org/index.php/pkpdsupport/comments/forensic_pharmacometrics (2016-04-25)
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  • Cognigen Corporation - Comments
    studies often up to 20 or more studies Just running a model up against 20 studies without having the graphical insight into your data is nothing more than a guessing game and a black box to the extended R D team Yet graphing of 20 studies with a time crunched deadline seems impossible At Cognigen we have developed a suite of processes requirement standards templates macros and technologies that allow our modelers to be able to spend the time thinking about your data by looking at the exploratory graphical analyses with your extended team Through this process we understand what the impact on the model will be and what it means to your develpment program With this knowledge and insight our modelers then are able to systematically approach model building to acheive the best predictions possible for the your critical decision making milestones You ve trusted Cognigen to build your NONMEM datasets now join us to actively discuss your project as Data Loves Discussion Call us at 1 716 633 3463 or Send us a note You have chosen to email the article entitled Graph Library and Standards Your Name Your Email Friends Name Friends Email Comments 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 graph library and standards Please enter the word you see in the image below Required Field System quality is defined in terms of customer satisfaction not requirements satisfaction Jeffrey Schmidt 1993 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

    Original URL path: http://nonmem.org/index.php/pkpdsupport/comments/graph_library_and_standards (2016-04-25)
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  • Cognigen Corporation - Comments
    how this information relates to the structure and content of the analysis ready dataset The Analyst then selects desired variables from the requirements form To facilitate variable selection the analyst can choose the therapeutic area of interest from a list of available therapeutic areas Selecting the therapeutic area for the pharmacometric analysis automatically populates the requirements with appropriate fields Once variables have been selected the analysis specific requirements are generated The selected variables have default labels units codes decodes and formats which can easily be changed to support an analysis The analyst can also select imputation methods for each relevant variable from a list of potential imputation strategies Once the Analyst completes the requirements the information is delivered to the data programmer With these clear and concise requirements in hand programming time is reduced and quality of the resulting analysis dataset increased Over the past 25 years Cognigen a Simulations Plus company has developed and formalized a systematic process for the assembly of data to support pharmacometric model development efforts In regularly working with multiple clients on numerous compounds in a variety of different therapeutic areas we have developed robust dataset specifications to handle the many possible variations in data collection study designs and data content These experiences have been distilled into concise requirements forms that ensure the reliable delivery of analysis ready datasets As always the goal is to allow ample time for model development and interpretation of results to support decision making at critical milestones Send us a note or call us at 1 716 633 3463 ext 229 for additional information Read more about our Pharmacometric Support Services Read more about all our Services Read more about KIWI a cloud based modeling and communication platform Read more about SimulationsPlus Suite of Software for In Silico Modeling You

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