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Cognigen Corporation - Posters and Presentations
Pre-2006
Pre-2000
AAPS 1996
Implementation of Concentration Dependent 'First-Pass' Models using NONMEM
Collegium Internationale Neuro-Psychopharmacologicum (CINP) 1998
Efficacy of Bupropion SR on Reducing Craving in Smoking Cessation
AAPS 1999
Phase III Population Pharmacokinetics and Pharmacodynamics of Azimilide
Publications Pre-2000
2000
AAPS 2000
Influence of Dose Size on Dose Response Relationships for Linezolid Efficacy Using Monte Carlo Simulations
DIA 2000
An Electronic Strategy for Implementing a New Paradigm in Pediatric Drug Development
The Role of Population PK/PD Analysis During the Implementation of a Bridging Strategy for Linezolid
Internet Based Communication Strategies to Support Linezolid Bridging Programs During Global Drug Development
Integration of Pharmaceutical Product Development in Asia/Japan Into the Global Program
ICAAC 2000
Population Pharmacodynamic (PD) Assessment of Linezolid Efficacy in Community Acquired Pneumonia, Skin and Soft Tissue Infections, and Bacteremia
Time Course Distributions of Laboratory Indices: A strategy for Evaluating Laboratory Data from Clinical Trials
Population Pharmacokinetics (PK) of Linezolid in Patients with Community-Acquired Pneumonia (CAP) and Skin and Soft Tissue (SST) Infections
2001
AAPS 2001
Population Pharmacokinetics/Pharmacodynamics (PK/PD) of Antidepressant R, R(-) and S, S(+) Reboxetine (RBX)
DIA 2001
A New Paradigm in Pediatric Drug Development: The Application of Cognitive Engineering
Integrating Real-Time Data Assembly (RTDA) and Population Pharmacokintics as Tactical Components of Cognitive Engineering
Transcend Global and Corporate Boundaries During Drug Development
ICAAC 2001
Population Pharmacokinetic (PK) Analysis of Gatifloxacin in Pediatric Patients
Population Pharmacodynamic (PD) Assessment of the Safety and Antiretrovial Activity of Atazanavir (BMS-232632)
Gatifloxacin in Children with Recurrent Otitis Media (ROM): Application of Real-Time Data Assembly (RTDA) and Sparse PK Sampling in Clinical Development
Publications 2001
2002
AAPS 2002
Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic (PPK) Methods
Evaluation of the Relationship Between Sumanirole Exposure and Orthostatic Hypotension
Evaluation of Covariate Effects on Population Pharmacokinetics (PPK) of Both Parent Drug and Metabolite(s) from Clinical Trial Data without Metabolite Administration or Excretion Sampling
ACCP 2002
Factors Influencing the Pharmacokinetics (PD) of Anticancer Drug Irinotecan (CPT-11) and its Major Metabolites, SN-38 and SN38G
ASCPT 2002
Population Modeling to Guide Phase 3 Dose Selection for AC2993 (Synthetic Exendin-4)
Comparison of Linezolid Pharmacokinetics (PK) from Phase I Studies of Japanese and Caucasians
Comparison of Laboratory Safety Data from Japanese and Non-Japanese in Linezoliid Phase I Studies
Cognitive Engineering - The Tools, Mindset, and Strategy for Integrated Development
Simultaneous Population Pharmacokinetic (PPK) Modeling of Irinotecan (CPT-11) and its Major Metabolites, SN-38 and SN-38G
Uniqueness of Solutions to Compartmental Models of Population Pharmacokinetics for Drugs Ungergoing Complex Metabolism
DIA 2002
A New Paradigm of Real-Time Data Assembly to Support Knowledge-Based Decision Making: A Case Study
Comparison of Post-Operative Nosocomial Infection Associated with Blood Management Techniques in Cardiovascular and Orthopedic Surgery
ECPAG 2002
Change-Point Models: Some Considerations in Implementation
Diagnosing Problems with Ka Estimation Due to Sparse Sampling
ICAAC 2002
Population Pharmacokinetics (PK) of Linezolid in Neonates and Young Infants
Population Pharmacodynamic Assessment of Atazanavir (BMS-232632) Exposure, Genotype, and Safety
The Application of Monte Carlo Simulation to the Estimation of Susceptibility Breakpoints
Pharmacodynamic Comparisons of Different Dosing Regimens of Penicillin G Against Penicillin-Susceptible and -Resistant Pneumococci
Monte Carlo Simulation and New Cefotaxime, Ceftriaxone, and Cefepime Susceptibility Breakpoints for S. pneumoniae, Including Strains with Reduced Susceptibility to Penicillin
A Novel Application of Monte Carlo Simulation to Compare PK-PD Target Attainment Rates for Oral Time-Dependent Antimicrobial Regimens
Impact of Pharmacokinetic and Microbiological Variability on the Pharmacodynamics of Gatifloxacin against S. pneumoniae in Children
Use of Monte Carlo Simulation to Evaluate the Antibacterial Activity of Garenoxacin Against Gram-Positive Bacteria
IDSA 2002
Relationships Between Susceptibility of Streptococcus pneumoniae against Levofloxacin & Hospital- & Patient-Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
Gatifloxacin and the Elderly: PK-PD Rationale for Potential Age-Related Dose Reduction
Minimum Efficacy and Mutation Prevention Exposure Target Attainment Rates Against Streptococcus pneumoniae for Levofloxacin 500 mg and 750 mg and Moxifloxacin 400 mg
Pharmacodynamics of Gatifloxacin 400 mg, Levofloxacin 500 mg and 750 mg and Moxifloxacin 400 mg Against Ciprofloxacin-Resistant Streptococcus pneumoniae
Pharmacokinetics/Pharmacodynamics in Otitis Media: Comparison of Time-Dependent Antibiotics in Middle Ear Fluid
PharmaSUG 2002
Rapid Assessment of Dataset Structures
Publications 2002
2003
AAPS 2003
Comparison of Parametric (NONMEM) and Non-Parametric (NPEM) Methods for Population Pharmacokinetic (PK) Modeling of Bi-Model Populations
Pharmacokinetic Analysis of Gatifloxacin in Plasma and Sinus Aspirate During Treatment of Acute Maxillary Sinusitis
Population PK/PD for Managers: From Identifying and Maximizing the Value-Add to Considerations for Implementation
The Implementation of Population PK/PD in Pediatric Drug Development
ASCPT 2003
Pharmacokinetic/Pharmacodynamic Analysis of Data from a Phase III Trial of Linezolid IV/PO for the Treatment of Resistant Gram-Positive Bacterial Infections in Children
Comparison of Censored Regression (CR) vs. Standard Regression (SR) Analyses for Modeling Relationships Between Minimum Inhibitory Concentrations (MIC) and Patient- and Institution-Specific Variables
Application of Real-Time Data Assembly (RTDA) to a Pivotal Phase III Pediatric Trial: A Proactive Approach to Population Pharmacokinetic/Pharmacodynamic (PK/PD) Dataset Creation
DIA 2003
Practical Approaches to Utilizing Exposure-Response Relationships to Inform Drug Development and Prescribing Decision-Making
ECCMID 2003
Relationships Between Susceptibility of Enterobacter spp. and Hospital- and Patient-Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
Relationships Between Susceptibility of Streptococcus pneumoniae and Hospital- and Patient-Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
Relationships Between Susceptibility of Pseudomonas aeruginosa and Hospital- and Patient-Specific Variables: Report from the Antimicrobial Resistance Rate Epidemiology Study Team (ARREST Program)
ICAAC 2003
PK-PD Target Attainment with Monte Carlo Simulation as Decision Support of Phase 2 / 3 Dosing Strategies for the Clinical Development of Doripenem
Relationship Between Increased Levofloxacin Use and Decreased Susceptibility of Streptococcus pneumoniae : Report From the ARREST Program
Characterization of Oritavancin Pharmacokinetics (PK) in Plasma and Blister Fluid in Nornam Healthy Volunteers
Serial Sinus Aspirate Sampling (SSAS): A Novel Technique for Evaluating Antimicrobial Therapy of Acute Maxillary Sinusitis (AMS)
Development of a Novel Population Pharmacokinetic (PK)-Based Method to Describe the Time-Course of Gatifloxacin (GAT) Middle Ear Fluid (MEF) Concentrations in Children
Population Pharmacokinetics (PK and Pharmacodynamics (PD) of Gatifloxacin (GAT) Plasma and MIddle Ear Fluid (MEF) Concentrations in Pediatric Patients with Acute Otitis Media Treatment Failures (AOM-TF) and/or Recurrent Otitis Media (ROM)
IDSA 2003
PK- PD Evaluation of Doripenem (DOR) Against Extended Spectrum ß- Lactamase (ESBL) Producing Enterobacteraceae
Antimicrobial Surveillance Programs: Can these Databases be Helping in Identifying Relationships Predictive of Resistance and be Applied to Patient Care?
Gatifloxacin Exposure in Maxillary Sinus and Middle Ear – All Sites of Infection Are Not Created Equal
Publications 2003
2004
AAPS 2004
An Historical Review of the Incorporation of UGT 1A1 Genotype in Population of UGT 1A1 Genotype in Population Analyses of Atazanav
Effect of Hepatic Impairment on the Pharmacokinetics of the Novel Glycopeptide Oritavancin
Evaluation of the Bias and Precision of Bayesian Parameter Estimates When Applying a Phase I Model to Sparse Patient Data
ASA 2004
Blood Management and Infections in Cardiovascular and Orthopedic Surgery
ASCO 2004
Pharmacogenomic and Pharmacokinetic Assessment of Liposome Encapsulated SN-38 (LE-SN38) in Advanced Cancer Patients
ASCPT 2004
A Novel Pharmacodynamic Model for Gatifloxacin vs. Salmonella typhi in Timed Kill Curves
DIA 2004
The Role of Exposure-Response Evaluations in Global Drug Development
ECCMID 2004
Use of an in vitro Pharmacodynamic Model & Monte Carlo Simulation to Characterize the Pharmacokinetics and Pharmacodynamics of Gatifloxacin vs Salmonella Typhi
Pharmacokinetics (PK) of Tigecycline (TG) in Healthy Adult Volunteers and in Subjects with Renal Impairment
IARS 2004
The Impact of Mivacurium and Rocuronium on Recovery Times in Ambulatory Anesthesia Procedures
ICAAC 2004
Monte Carlo Simulation to Estimate in VITRO susceptibility breakpoints for Moxifloxacin, Gatifloxacin, and Levofloxacin against Staphylococcus Aureus
Population Pharmacokinetics of Tigecycline in Phase 1 Subjects
Population Pharmacokinetics of Doripenem
SABM 2004
Postoperative Infection Rate Following Cardiac Surgery with Allogeneic vs. other Blood Management Techniques
Publications 2004
2005
AAPS 2005
Population Pharmacokinetics of Tigecycline in Patients with Complicated Intra-abdominal or Skin and Skin-Structure Infections
Population Pharmacokinetics of Modafinil Film-Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
ASCO 2005
Development of a Pharmacokinetic (PK) Model and Assessment of Patient (PT) Covariate Effects on Dose-Dependent PK following Different Dosing Schedules in Two Phase I Trials of AP23573 (AP), an mTOR Inhabitor
ECCMID 2005
Pharmacodynamic Characterization of NVP-LMB415 against Haemophilus influenzae in an In Vitro Hollow-Fiber System
Exposure-Response Analysis of the Efficaccy of Tigecycline in Patients with complicated skin and skin-structure infected infections
Pharmacokinetic/Pharmacodynamic model for the tolerability of Tigecycline in healthy volunteers
A novel approach for evaluating the microbiological efficacy of Tigecycline in patients with complicated skin and skin-structure infections
ICAAC 2005
Population Pharmacokinetics of Tigecycline in Patients with Complicated Intra-abdominal or Skin and Skin-Structure Infections
Exposure-Response Analysis of the Efficacy of Tigecycline in Patients with Complicated Intra-Abdominal Infections (cIAI)
Estimation of In VitroSusceptibility Breakpoints for Tigecycline Against Staphylococcus aureus
Estimation of In VitroSusceptibility Breakpoints for Tigecycline Against Enterobacteriaceae
Noncompartmental Pharmacokinetics of Tigecycline in Phase 3 Studies of Patients with Complicated Skin and Skin-Structure and Intra-Abdominal Infections
IDSA 2005
Pharmacokinetic/Pharmacodynamic Model for the Safety of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections
Publications 2005
Publications- Pre-2000 - 2005
2006
AAPS 2006
Population Pharmacokinetics of (R)-Albuterol Following Inhaled Levalbuterol or Racemic Albuterol via a Hydrofluoroalkane Metered Dose Inhaler in Pediatric and Adult Asthma Patients
Modeling & Simulation Learn to Speak the Language: Modeling
ASCPT 2006
Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Tolvaptan in Healthy Subjects
ASCO 2006
ECCMID 2006
Pharmacokinetic/Pharmacodynamic (PK/PD) Model for the Safety of Tigecycline (T) in Patients with Complicated Intra-Abdominal Infections (cIAI)
ERS 2006
Population Pharmacokinetics of Nebulized Arformoterol in Subjects with COPD
Exposure-Response Relationship for Nebulized Arformoterol in Subjects with COPD
Publications 2006
2007
AAPS 2007
Influence of Estimation of Inter-Occasion Variability on Detection of Time-Varying Covariates
ASCO 2007
Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Hepatoprotective Effect of Dexamethasone on Transient Transaminitis After Trabectedin (ET-743, Yondelis®) Treatment
ASCPT 2007
Model-Based Evaluations to Select and Confirm Doses in the Clinical Development of Exenatide
Effect of Lifestyle Intervention on the Placebo Response in Anti-Obesity Trials: Considerations for Exposure-Response Modeling
Population Pharmacokinetics of Paliperidone ER in Healthy Subjects and Patients with Schizophrenia
PAGE 2007
The Application of Systematic Analysis for Identifying and Addressing the Needs of the Pharmacometric Process
Publications 2007
2008
ACoP 2008
Improving the Efficiency and Ensuring the Quality of Data Assembly for Pharmacometric Analysis
ASCPT 2008
Model Feasibility Assessment as a Driver for Model Based Drug Development
Population Pharmacokinetics of Bendamustine and Metabolites in Patients with Indolent Non-Hodgkin Lymphoma
Publications 2008
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