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  • Cognigen Corporation - Comments - data
    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

    Original URL path: http://nonmem.org/index.php/modeling_and_simulation/comments/data (2016-04-25)
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  • Cognigen Corporation - Comments
    entitled Simulations Plus Releases DDDPlus Version 5 0 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 simulations plus releases dddplus version 5 0 Please enter the word you see in the image below Required Field 3 Average days per year playing in the snow in Buffalo NY instead of work snow days 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 Impact of Delayed Dose Administration of USL255 Qudexy XR Topiramate Extended Release Capsules Tedizolid population pharmacokinetics exposure response and target attainment Exposure response analysis of eslicarbazepine acetate as adjunctive treatment of patients with partial onset seizures The development of a population pharmacokinetic PK model for linezolid Engineering the Pharmacometrics Enterprise Exposure response analyses of tigecycline

    Original URL path: http://nonmem.org/index.php/pkpdsupport/comments/data (2016-04-25)
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  • Cognigen Corporation - Contact US
    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 CA Article Published in Clinical Drug

    Original URL path: http://nonmem.org/index.php/cognigen/contact_us/ (2016-04-25)
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  • Cognigen Corporation - Results
    Hing J Loebel A Koblan K 2015 Download File Journal Article Nonclinical and pharmacokinetic assessments to evaluate the potential of tedizolid and linezolid to affect mitochondrial function Primary Authors Flanagan A McKee EE Das D Tulkens PM Hosako H Fiedler Kelly J Passarell J Radovsky A Prokocimer P Citation Antimicrob Agents Chemother 2015 59 1 178 185 2015 External Link Poster Population modeling is a critical element of bridging PK data from dried blood spot and plasma acros Conference American Association of Pharmaceutical Scientists AAPS November 2 6 2014 San Diego CA Primary Authors Dockendorf M Li C C Kowalski K Yang B Ma L Kleijn H Bosch R Forman M Marcantonio G Voss T Jaworowicz D Passarell J Bateman K Stone J Kothare P 2014 Download File Poster Population Pharmacokinetic Evaluation of Eslicarbazepine Acetate for Adjunctive Therapy in Conference American College of Clinical Pharmacy ACCP Atlanta Georgia September 2014 Primary Authors Ludwig E Sunkaraneni S Fiedler Kelly J Lu Q Maier G Blum D Kharidia J 2014 Download File Poster KIWI A Collaborative Platform for Modeling and Simulation Conference Population Approach Group in Europe PAGE Alicante Spain June 2014 Primary Authors Bihorel S Fox D Phillips L Fiedler Kelly J Rokitka A Walawander C Grasela T 2014 Download File Journal Article An evaluation of the potential for drug drug interactions between bendamustine and rituximab in indolent nonHodgkin lymphoma and mantle cell lymphoma Primary Authors Darwish M Burke J M Hellriegel E Robertson Jr P Phillips L Ludwig E Munteanu M C Bond M Citation Cancer Chemother Pharmacol 2014 73 6 1119 27 2014 External Link Poster Impact of Delayed Dose Administration of USL255 Qudexy XR Topiramate Extended Release Capsules Conference Annual American Academy of Neurology AAN Philadelphia Pennsylvania April 2014 Primary Authors Anders B Ludwig E Clark A M 2014 Download File Poster Tedizolid Plasma Pharmacokinetics Are Comparable in Obese and Nonobese Patients and Healthy Subjects Conference European Congress of Clinical Microbiology and Infectious Diseases ECCMID Barcelona Spain May 2014 Primary Authors Flanagan S Minassian S L Passarell J A Fiedler Kelly J B Prokocimer P 2014 Download File Poster Population Pharmacokinetic Evaluation of Eslicarbazepine Acetate for Adjunctive Therapy in Refractory Partial Onset Seizures Conference American Association of Pharmaceutical Scientists AAPS San Antonio Texas November 2013 Primary Authors Lu Q Ludwig E Fiedler Kelly J Maier G Blum D Kharidia J 2014 Download File Poster Tedizolid population pharmacokinetics exposure response and target attainment Conference Interscience Conference on Antimicrobial Agents and Chemotherapy ICAAC Denver Colorado September 2013 Primary Authors Flanagan S Passarell J Lu Q Fiedler Kelly J Prokocimer P 2013 Download File Journal Article A population pharmacokinetic and pharmacodynamic analysis of peginesatide in patients with chronic kidney disease on dialysis Primary Authors Naik H Tsai MC Fiedler Kelly J Qiu P Vakilynejad M Citation PLoS One 2013 8 6 e66422 2013 External Link Poster Pharmacokinetic profile of an ascending dose estrogen progestin combination oral contraceptive Conference Society for Gynecologic Investigation SGI Orlando FL March 2013 Primary Authors Darwish M

    Original URL path: http://nonmem.org/index.php/presentations/results/P15 (2016-04-25)
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  • Cognigen Corporation - Results
    E Grasela T Fiedler Kelly J Maier G Soares da Silva P 2011 Download File Poster Exposure response analysis of eslicarbazepine acetate as adjunctive treatment of patients with partial onset seizures Conference American College of Clinical Pharmacy ACCP Pittsburgh Pennsylvania October 2011 Primary Authors Kharidia J Passarell J Maier G Zummo J Ludwig E Grasela T Fiedler Kelly J 2011 Download File Poster Pharmacokinetic PK and pharmacodynamic PD modeling of subcutaneous SC LY2189102 a neutralizing IL 1 beta antibody in patients with type 2 diabetes mellitus Conference European Association for the Study of Diabetes EASD Lisbon Portugal September 2011 Primary Authors Abu Raddad E DeGaetano A Bihorel S Fiedler Kelly J Sloan Lancaster J 2011 Download File Poster Semi mechanistic PK PD model of the effect of odanacatib a cathepsin K inhibitor on bone turnover to characterize lumbar spine and distal forearm bone mineral density in a Phase IIb study of postmenopausal women Conference Population Approach Group in Europe PAGE Athens Greece June 2011 Primary Authors Zajic S Stone J A Jaworowicz D Leung A Le Thi Duong Passarell J Fiedler Kelly J Cohn D Verbruggen N Stoch A 2011 Download File Poster A semi mechanistic approach to PK PD modeling of complex response data bone turnover example for odanacatib a cathepsin K inhibitor Conference American Conference on Pharmacometrics ACoP San Diego California April 2011 Primary Authors Stone J A Zajic S Jaworowicz D Leung A Le Thi Duong Passarell J Fiedler Kelly J Cohn D Verbruggen N Stoch A 2011 Download File Poster Mixture modeling as a data imputation method Conference American Conference on Pharmacometrics ACoP San Diego California April 2011 Primary Authors Willavize S Fiedler Kelly J Hanley W Mahnke L Hang Y Peng J Z Phillips L 2011 Download File Poster Population pharmacokinetics of eslicarbazepine acetate in patients with partial onset seizures Conference American Society for Clinical Pharmacology and Therapeutics ASCPT Dallas Texas March 2011 Primary Authors Kharidia J Lu Q Ludwig E Grasela T Fiedler Kelly J Maier G Soares da Silva P 2011 Download File Poster Exposure response analysis of eslicarbazepine acetate as adjunctive treatment of patients with partial onset seizures Conference American Society for Clinical Pharmacology and Therapeutics ASCPT Dallas Texas March 2011 Primary Authors Passarell J Kharidia J Maier G Ludwig E Grasela T Fiedler Kelly J Soares da Silva P 2011 Download File Publication Improving the quality and productivity of pharmacometric modeling and simulation activities the foundation for model based drug development Primary Authors Grasela T H Fiedler Kelly J Slusser R 2011 External Link Poster New to an organization tools to assess projects and teams Conference Project Management Institute PMI Pharmaceutical Community of Practice CoP Durham North Carolina March 2011 Primary Authors Walawander C A Grasela T H Zelasko T Willetts T Gomathinayagam V Tsai C F Macri J 2011 Download File Poster Semi mechanistic PK PD model of the effect of odanacatib a cathepsin K inhibitor on bone turnover to characterize lumbar spine bone mineral density in two Phase II

    Original URL path: http://nonmem.org/index.php/presentations/results/P30 (2016-04-25)
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  • Cognigen Corporation - Results
    L Grasela T H Jr Freer J P Tack K J Schentag J J Citation Antimicrob Agents Chemother 1987 31 3 375 378 1987 External Link Journal Article An evaluation of population pharmacokinetics in therapeutic trials Part I Comparison of methodologies Primary Authors Grasela T H Jr Antal E J Townsend R J Smith R B Citation Clin Pharmacol Ther 1986 39 6 605 612 1986 External Link Journal Article Efficacy of theophylline for prevention of post extubation respiratory failure in very low birth weight infants Primary Authors Viscardi R M Faix R G Nicks J J Grasela T H Citation J Pediatr 1985 107 3 469 472 1985 External Link Journal Article Safety of a higher loading dose of phenobarbital in the term newborn Primary Authors Donn S M Grasela T H Goldstein G W Citation Pediatrics 1985 75 6 1061 1064 1985 External Link Journal Article Neonatal population pharmacokinetics of phenobarbital derived from routine clinical data Primary Authors Grasela T H Jr Donn S M Citation Dev Pharmacol Ther 1985 8 6 374 383 1985 External Link Journal Article Population pharmacokinetics of procainamide from routine clinical data Primary Authors Grasela T H Sheiner L B Citation Clin Pharmacokinet 1984 9 6 545 554 1984 External Link Journal Article Experience with NONMEM analysis of routine phenytoin clinical pharmacokinetic data Primary Authors Sheiner L B Grasela T H Citation Drug Metab Rev 1984 15 1 2 293 303 1984 External Link Journal Article Steady state pharmacokinetics of phenytoin from routinely collected patient data Primary Authors Grasela T H Sheiner L B Rambeck B Boenigk H E Dunlop A Mullen P W Wadsworth J Richens A Ishizaki T Chiba K Citation Clin Pharmacokinet 1983 8 4 355 364 1983 External Link Journal Article Phenytoin pharmacokinetics inappropriate data analysis Primary Authors Grasela

    Original URL path: http://nonmem.org/index.php/presentations/results/P270 (2016-04-25)
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  • Cognigen Corporation - Engineering the Pharmacometrics Enterprise
    Releases DDDPlus Version 5 0 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 presentations comments simulations plus releases dddplus version 5 0 Please enter the word you see in the image below Required Field The five why s of Toyota s learn manufacturing find the basic cause of a defect keep asking why from effect to cause five times Sakichi Toyoda 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 Impact of Delayed Dose Administration of USL255 Qudexy XR Topiramate Extended Release Capsules Tedizolid population pharmacokinetics exposure response and target attainment Exposure response analysis of eslicarbazepine acetate as adjunctive treatment of patients with partial onset seizures The development of a population pharmacokinetic PK model for linezolid Engineering the

    Original URL path: http://nonmem.org/index.php/presentations/comments/data (2016-04-25)
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  • Cognigen Corporation - Contact US
    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

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