Population Pharmacokinetics of Modafinil Film-Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Population Pharmacokinetics of Modafinil Film-Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Authors: Owen JS, Grasela TH, Robertson P, Darwish M
Conference: AAPS
Keywords: ADHD, age, central nervous system agents, full-profile, induction, neurology, NONMEM, PE%, pediatrics, PK, sparse sampling, validation, weight
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Modafinil is currently being evaluated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. A population pharmacokinetic model was developed…

Pharmacokinetic/Pharmacodynamic Model for the Safety of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections

Pharmacokinetic/Pharmacodynamic Model for the Safety of Tigecycline in Patients with Complicated Skin and Skin-Structure Infections

Authors: Meagher AK, Passarell JA, Liolios K, Cirincione B, Van Wart S, Grasela TH, Babinchak T, Ellis-Grosse EJ
Conference: IDSA
Keywords: age, anti-infectives, antibiotic, cSSSI, dermatology, dose, hosmer-lemeshow, infectious disease, intravenous, IV, Kaplan-Meier, logistic regression, males, nausea, PK/PD, region, ROC, SAS, vomiting
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Tigecycline is a first-in-class glycylcycline for the treatment of serious bacterial infections. Reported adverse events from clinical trials include nausea and vomiting. Exposure-response relationships and…

Challenges in the transition to model-based development

Challenges in the transition to model-based development

Authors: Grasela TH, Fiedler-Kelly J, Walawander CA, Owen JS, Cirincione BB, Reitz KE, Ludwig EA, Passarell JA, Dement CW
Publication: AAPS J
Keywords: animals, decision-making, guidelines, humans, methods, Models: Theoretical, pharmacokinetics, Technology: Pharmaceutical
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Practitioners of the art and science of pharmacometrics are well aware of the considerable effort required to successfully complete modeling and simulation activities...

An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery

An evaluation of the utility of physiologically based models of pharmacokinetics in early drug discovery

Authors: Parrott N, Paquereau N, Coassolo P, Lavé T
Publication: J Pharm Sci
Keywords: animals, area under curve, biological availability, biological models, blood, chemistry, computer simulation, drug design, intestinal absorption, metabolism, pharmaceutical preparations, pharmacokinetic, rats, solubility
Software: GastroPlus®

Generic physiologically-based models of pharmacokinetics were evaluated for early drug discovery.

Use of pharmacokinetic-pharmacodynamic target attainment analyses to support phase 2 and 3 dosing strategies for doripenem

Use of pharmacokinetic-pharmacodynamic target attainment analyses to support phase 2 and 3 dosing strategies for doripenem

Authors: Bhavnani SM, Hammel JP, Cirincione B, Wikler MA, Ambrose PG
Publication: Antimicrob Agents Chemother
Keywords: administration & dosage, adolescent, adult, aged, bacteria, bacterial infections, biological, Carbapenems, doripenem population, double-blind method, drug effects, female, humans, infusions, intravenous, male, Microbial Sensitivity Tests, microbiology, middle-aged, models
Division: Clinical Pharmacology and Pharmacometrics (CPP)

A doripenem population pharmacokinetic model and Monte Carlo simulations were utilized for dose regimen decision support for future clinical development.

Pharmacokinetic/pharmacodynamic profile for tigecycline-a new glycylcycline antimicrobial agent

Pharmacokinetic/pharmacodynamic profile for tigecycline-a new glycylcycline antimicrobial agent

Authors: Meagher AK, Ambrose PG, Grasela TH, Ellis-Grosse EJ
Publication: Diagn Microbiol Infect Dis
Keywords: administration & dosage, Age Factors, analogs & derivatives, animals, anti-bacterial agents, antibio, bacteria, bacterial infections, blister, glycylcycline, half-life, humans, infusions, intravenous, metabolism, Microbial Sensitivity Tests, Minocycline, pharmacokinetics, Tigecycline
Division: Clinical Pharmacology and Pharmacometrics (CPP)
Antimicrobial safety: focus on fluoroquinolones

Antimicrobial safety: focus on fluoroquinolones

Authors: Owens RC, Ambrose PG
Publication: Clin Infect Dis
Keywords: 80 and over, adult, adverse effects, aged, Anaphylaxis, animals, Arrhythmias, cardiac, chemically induced, chemistry, child, clinical trials, Dermatitis, Enterocolitis, fluoroquinolones, glucose, headache, homeostasis, humans, Phototoxic, Pseudomembranous
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Infrequent toxicities associated with certain drugs and drug classes have recently gained much attention from different health-care perspectives.

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 Inhibitor

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 Inhibitor

Authors: Desai AA, Mita M, Fetterly GJ, Chang C, Netsch M, Knowles HL, Bedrosian CL, Rowinsky E, Tolcher A, Ratain MJ
Conference: ASCO
Keywords: antineoplastics, body surface area, BSA, cancer, dose, dose-limiting toxicity, maximum tolerated dose, MTD, mucositis, Oncology, RBC, red blood cell, safety, WinNonlin
Division: Clinical Pharmacology and Pharmacometrics (CPP)

AP23573 is a novel non-prodrug rapamycin analog that potently inhibits mTOR (through bivalent binding to FKBP and mTOR), a downstream effector of PI3K/Akt and nutrient-sensing pathways. A PK model was…

Application of an in vitro infection model and simulation for reevaluation of fluoroquinolone breakpoints for Salmonella enterica serotype typhi

Application of an in vitro infection model and simulation for reevaluation of fluoroquinolone breakpoints for Salmonella enterica serotype typhi

Authors: Booker BM, Smith PF, Forrest A, Bullock J, Kelchlin P, Bhavnani SM, Jones RN, Ambrose PG
Publication: Antimicrob Agents Chemother
Keywords: administration & dosage, anti-infective agents, area under curve, ciprofloxacin, computer simulation, Dose-Response Relationship, drug, drug effects, drug therapy, fluoroquinolone therapy, fluoroquinolones, half-life, in vitro, infection, Microbial Sensitivity Tests, microbiology
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Salmonella enterica serotype Typhi and nontyphoidal Salmonella remain major causes of morbidity and mortality worldwide.

Pharmacodynamic Characterization of NVP-LMB415 against Haemophilus Influenzae in an In Vitro Hollow-Fiber System

Pharmacodynamic Characterization of NVP-LMB415 against Haemophilus Influenzae in an In Vitro Hollow-Fiber System

Authors: Meagher AK, Smith P, Forrest A, Ogundele A, Ambrose PG
Conference: ECCMID
Keywords: anti-infectives, antibiotic, AUC:MIC ratio, CFU, continuous infusion, exposure-response, H flu, H influenzae, infectious disease, PK/PD, resistance
Division: Clinical Pharmacology and Pharmacometrics (CPP)

NVP-LBM415 is a peptide deformylase inhibitor with in vitro activity against those pathogens commonly associated with community-acquired respiratory tract infections. The purpose of these studies was to…

Exposure-Response Analysis Of The 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

Authors: Meagher AK, Passarell JA, Cirincione B, Van Wart S, Liolios K, Babinchak T, Ellis-Grosse EJ, Ambrose PG
Conference: ECCMID
Keywords: anti-infectives, antibiotic, AUC:MIC ratio, CART, classification and regression tree, cSSSI, dermatology, exposure-response, GEE, infectious disease, IV, logistic regression, pharmacodynamic, PK/PD, S-Plus, s.aureus, SAS, staphylococcus, steady state, streptococcus
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Tigecycline, the first glycylcycline to reach clinical trials, is in development for the treatment of patients with serious infections, including complicated skin and skin-structure infections (cSSSI).