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Cognigen Corporation - Posters and Presentations
Cognigen Corporation
Clinical
Cardiac Disorders
Posters
Arrhythmias
Phase III Population Pharmacokinetics and Pharmacodynamics of Azimilide
Congestive Heart Failure
Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Tolvaptan in Healthy Subjects
Publications
Endocrine Disorders
Posters
Diabetes Mellitus
Model-Based Evaluations to Select and Confirm doses in the Clinical Development of Exenatide
Population Modeling to Guide Phase 3 Dose Selection for AC2993 (Synthetic Exendin-4)
Publications
Hepatobiliary Disorders
Posters
Hepatic Impairment
Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Hepatoprotective Effect of Dexamethasone on Transient Transaminitis After Trabectedin (ET-743, Yondelis®) Treatment
Effect of Hepatic Impairment on the Pharmacokinetics of the Novel Glycopeptide Oritavancin
Publications
Immune System Disorders
Posters
Publications
Infections and Infestations
Posters
Antimicrobial Resistence
Comparison of Censored Regression (CR) vs. Standard Regression (SR) Analyses for Modeling Relationships Between Minimum Inhibitory Concentrations (MIC) and Patient- and Institution-Specific Variables
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 Pseudomonas aeruginosa 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)
Antimicrobial Surveillance Programs: Can these Databases be Helpful in Identifying Relationships Predictive of Resistance and be Applied to Patient Care?
Pharmacokinetics/Pharmacodynamics in Otitis Media: Comparison of Time-Dependent Antibiotics in Middle Ear Fluid
Monte Carlo Simulation & PK-PD Target Attainment Analysis: Application to Estimation of MIC Breakpoints
Monte Carlo Simulation & PK-PD Target Attainment Analysis: Application to Oral Time-Dependent Antimicrobial Regimens
Carbapenems
Population Pharmacokinetics of Doripenem
PK-PD Target Attainment with Monte Carlo Simulation as Decision Support of Phase 2 / 3 Dosing Strategies for the Clinical Development of Doripenem
PK- PD Evaluation of Doripenem (DOR) Against Extended Spectrum ß- Lactamase (ESBL) Producing Enterobacteraceae
Fluoroquinolone
A Novel Pharmacodynamic Model for Gatifloxacin vs. Salmonella Typhi in Timed Kill Curves
Use of an in vitro Pharmacodynamic Model & Monte Carlo Simulation to Characterize the Pharmacokinetics and Pharmacodynamics of Gatifloxacin vs Salmonella Typhi
Monte Carlo Simulation to Estimate in VITRO susceptibility breakpoints for Moxifloxacin, Gatifloxacin, and Levofloxacin against Staphylococcus Aureus
Development of a Novel Population Pharmacokinetic (PK)-Based Method to Describe the Time-Course of Gatifloxacin (GAT) Middle Ear Fluid (MEF) Concentrations in Children
Serial Sinus Aspirate Sampling (SSAS): A Novel Technique for Evaluating Antimicrobial Therapy of Acute Maxillary Sinusitis (AMS)
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)
Relationship Between Increased Levofloxacin Use and Decreased Susceptibility of Streptococcus pneumoniae : Report From the ARREST Program
Pharmacokinetic Analysis of Gatifloxacin in Plasma and Sinus Aspirate During Treatment of Acute Maxillary Sinusitis
Gatifloxacin and the Elderly: PK-PD Rationale for Potential Age-Related Dose Reduction
Use of Monte Carlo Simulation to Evaluate the Antibacterial Activity of Garenoxacin Against Gram-Positive Bacteria
Pharmacodynamics of Gatifloxacin 400 mg, Levofloxacin 500 mg and 750 mg and Moxifloxacin 400 mg Against Ciprofloxacin-Resistant Streptococcus Pneumoniae
Minimum Efficacy and Mutation Prevention Exposure Target Attainment Rates Against Streptococcus pneumoniae for Levofloxacin 500 mg and 750 mg and Moxifloxacin 400 mg
Gatifloxacin in Children with Recurrent Otitis Media (ROM): Application of Real-Time Data Assembly (RTDA) and Sparse PK Sampling in Clinical Development
Glycopeptide
Characterization of Oritavancin Pharmacokinetics (PK) in Plasma and Blister Fluid in Nornal Healthy Volunteers
Glycylcyclines
Pharmacokinetic/Pharmacodynamic (PK/PD) Model for the Safety of Tigecycline (T) in Patients with Complicated Intra-Abdominal Infections (cIAI)
Pharmacokinetic/Pharmacodynamic Model for the Safety of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections
A Novel Approach for Evaluating the Microbiological Efficacy of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections
Exposure-Response Analysis of the Efficacy of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections
Pharmacokinetic/Pharmacodynamic Model for the tolerability of Tigecycline in healthy volunteers
Estimation of In VitroSusceptibility Breakpoints for Tigecycline Against Enterobacteriaceae
Estimation of In Vitro Susceptibility Breakpoints for Tigecycline Against Staphylococcus aureus
Exposure-Response Analysis of the Efficacy of Tigecycline in Patients with Complicated Intra-Abdominal Infections (cIAI)
Noncompartmental Pharmacokinetics of Tigecycline in Phase 3 Studies of Patients with Complicated Skin and Skin-Structure and Intra-Abdominal Infections
Population Pharmacokinetics of Tigecycline in Patients with Complicated Skin and Skin-Structure and Intra-Abdominal Infections
Pharmacokinetics (PK) of Tigecycline (TG) in Healthy Adult Volunteers and in Subjects with Renal Impairment
Population Pharmacokinetics of Tigecycline in Phase 1 Subjects
HIV
Population Pharmacodynamic Assessment of Atazanavir Exposure, Uridine Diphosphate-0Glucuronosyl Transferase (UGT) 1A1 Genotype and Safety in Healthy Subjects
An Historical Review of the Incorporation of UGT 1A1 Genotype in Population Analyses of Atazanavir
Population Pharmacodynamic (PD) Assessment of the Safety and Antiretrovial Activity of Atazanavir (BMS-232632)
Oxazolidinone
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 Laboratory Safety Data from Japanese and Non-Japanese in Linezolid Phase I Studies
Comparison of Linezolid Pharmacokinetics from Phase I Studies of Japanese and Caucasians
Population Pharmacokinetics (PK) of Linezolid in Neonates and Young Infants
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
Population Pharmacodynamic Assessment of Linezolid Efficacy in Community Acquired Pneumonia, Skin and Soft Tissue Infections, and Bacteremia
Penicillins
Pharmacodynamic Comparisons of Different Dosing Regimens of Penicillin G Against Penicillin-Susceptible and -Resistant Pneumococci
Peptide Deformylase Inhibitors
Pharmacodynamic Characterization of NVP-LMB415 against Haemophilus influenzae in an In Vitro Hollow-Fiber System
Surgical Complications
Blood Management and Infections in Cardiovascular and Orthopedic Surgery
Postoperative Infection Rate Following Cardiac Surgery with Allogeneic vs. other Blood Management Techniques
Comparison of Post-Operative Nosocomial Infection Associated with Blood Management Techniques in Cardiovascular and Orthopedic Surgery
Publications
Metabolism and Nutrition Disorders
Posters
Obesity
Effect of Lifestyle Intervention on the Placebo Response in Anti-Obesity Trials: Considerations for Exposure-Response Modeling
Diabetes Mellitus
Model-Based Evaluations to Select and Confirm Doses in the Clinical Development of Exenatide
Population Modeling to Guide Phase 3 Dose Selection for AC2993 (Synthetic Exendin-4)
Publications
Neoplasms Benign, Malignant and Unspecified
Posters
mTOR Inhibitors
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
Tetrahydroisoquinoline Alkaloids
Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Hepatoprotective Effect of Dexamethasone on Transient Transaminitis After Trabectedin (ET-743, Yondelis®) Treatment
Topoiscmerase Inhibitors
Pharmacogenomic and Pharmacokinetic Assessment of Liposome Encapsulated SN-38 (LE-SN38) in Advanced Cancer Patients
Factors Influencing the Pharmacokinetics (PK of the Anticancer Drug Irinotecan (CPT-11) and its Major Metabolites, SN-38 and SN-38G
Simultaneous Population Pharmacokinetic (PPK) Modeling of Irinotecan (CPT-11) and its Major Metabolites, SN-38 and SN-38G
Publications
Nervous System Disorders
Posters
Parkinson's Disease
Lack of Significant Drug Interactions for Sumanirole in Phase II Studies Using Population Pharmacokinetic Methods
Evaluation of the Relationship Between Sumanirole Exposure and Orthostatic Hypotension
Publications
Psychiatric Disorders
Posters
ADHD
Population Pharmacokinetics of Modafinil Film-Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Depression
Population Pharmacokinetics/Pharmacodynamics of Antidepressant R, R(-) and S, S(+) Reboxetine (RBX)
Publications
Renal and Urinary Disorders
Posters
Renal Impairment
Pharmacokinetics (PK) of Tigecycline (TG) in Healthy Adult Volunteers and in Subjects with Renal Impairment
Publications
Respiratory, Thoracic and Mediastinal Disorders
Posters
Asthma
Population Pharmacokinetics of (R)-Albuterol Following Inhaled Levalbuterol or Racemic Albuterol via a Hydrofluoroalkane Metered Dose Inhaler in Pediatric and Adult Asthma Patients
COPD
Population Pharmacokinetics of Nebulized Arformoterol in Subjects with COPD
Exposure-Response Relationship for Nebulized Arformoterol in Subjects with COPD
Publications
Social Circumstances
Posters
Geriatrics
Gatifloxacin and the Elderly: PK-PD Rationale for Potential Age-Related Dose Reduction
Pediatrics
The Implementation of Population PK/PD in Pediatric Drug Development
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
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)
Population Pharmacokinetics (PK) of Linezolid in Neonates and Young Infants
Impact of Pharmacokinetic and Microbiological Variability on the Pharmacodynamics of Gatifloxacin against S. pneumoniae in Children
A New Paradigm in Pediatric Drug Development: The Application of Cognitive Engineering
Population Pharmacokinetic (PK) Analysis of Gatifloxacin in Pediatric Patients
An Electronic Strategy for Implementing a New Paradigm in Pediatric Drug Development
Smoking Cessation
Efficacy of Bupropion SR on Reducing Craving in Smoking Cessation
Publications
Surgical and Medical Procedures
Posters
Anesthesia
The Impact of Mivacurium and Rocuronium on Recovery Times in Ambulatory Anesthesia Procedures
Infectious Complications
Blood Management and Infections in Cardiovascular and Orthopedic Surgery
Postoperative Infection Rate Following Cardiac Surgery with Allogeneic vs. other Blood Management Techniques
Comparison of Post-Operative Nosocomial Infection Associated with Blood Management Techniques in Cardiovascular and Orthopedic Surgery
Publications
Pharmacometrics
Cognitive Engineering
Posters
Cognitive Engineering - The Tools, Mindset, and Strategy for Integrated Development Standard
Publications
Drug Development
Posters
The Integration of Dose- and Exposure- Response Knowledge into Drug Development, Regulatory, and Clinical Decision-Making
Practical Approaches to Utilizing Exposure-Response Relationships to Inform Drug Development and Prescribing Decision-Making
The Role of Exposure-Response Evaluations in Global Drug Development
Transcend Global and Corporate Boundaries During Drug Development
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
Publications
Laboratory Parameters
Posters
Time Course Distributions of Laboratory Indices: A strategy for Evaluating Laboratory Data from Clinical Trials
Publications
Misc.
Posters
Publications
Modeling and Simulation
Posters
Modeling & Simulation Learn to Speak the Language: Modeling
Evaluation of the Bias and Precision of Bayesian Parameter Estimates When Applying a Phase I Model to Sparse Patient Data
Population PK/PD for Managers: From Identifying and Maximizing the Value-Add to Considerations for Implementation
Change-Point Models: Some Considerations in Implementation
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
Uniqueness of Solutions to Compartmental Models of Population Pharmacokinetics for Drugs Ungergoing Complex Metabolism
Problematic Estimation of Ka Using Peak-Trough Sampling Schemes
Rapid Assessment of Dataset Structures
Influence of Dose Size on Dose Response Relationships for Linezolid Efficacy Using Monte Carlo Simulations
The Application of Systematic Analysis for Identifying and Addressing the Needs of the Pharmacometric Process
Publications
NONMEM
Posters
Influence of Estimation of Inter-Occasion Variability on Detection of Time-Varying Covariates
Comparison of Parametric (NONMEM) and Non-Parametric (NPEM) Methods for Population Pharmacokinetic (PK) Modeling of Bi-Model Populations
Implementation of Concentration Dependent 'First-Pass' Models using NONMEM
Publications
Real-time Data Assembly
Posters
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
A New Paradigm of Real-Time Data Assembly to Support Knowledge-Based Decision Making: A Case Study
Integrating Real-Time Data Assembly (RTDA) and Population Pharmacokinetics as Tactical Components of Cognitive Engineering
Publications
Statistics
Posters
Comparison of Censored Regression (CR) vs. Standard Regression (SR) Analyses for Modeling Relationships Between Minimum Inhibitory Concentrations (MIC) and Patient- and Institution-Specific Variables
Publications
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