An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part II. Detection of a Drug-Drug Interaction

An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part II. Detection of a Drug-Drug Interaction

Authors: Grasela TH, Antal E, Ereshefsky L, Wells BG, Evans RL, Smith RB
Publication: Clin Pharmacol Ther
Keywords: administration, adult, alprazolam, blood, central nervous system agents, comparative study, dosage, drug interactions, evaluation studies, humans, imipramine, male, pharmacokinetics, PKPD methodology, population, psychiatry, psychotherapeutic agents, regression analysis, research, research design, research support, soft
Division: Clinical Pharmacology and Pharmacometrics (CPP)

The use of observational data, collected during the routine clinical care of patients, has been advocated as a means to obtain clinically relevant information regarding the pharmacokinetic parameters of...

Determinants of antibiotic-associated hypoprothrombinemia

Determinants of antibiotic-associated hypoprothrombinemia

Authors: Schentag JJ, Welage LS, Grasela TH, Adelman MH
Publication: Pharmacotherapy
Keywords: adverse effects, adverse events, anti-bacterial agents, bacteria, Blood Coagulation, cefoperazone, cephalosporins, chemically induced, comparative study, drug effects, hematology, humans, hypoprothrombinemias, in vitro, moxalactam, Prothrombin Time, risk
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Hypoprothrombinemia is a relatively uncommon event in the hospitalized patient. When it does occur, it often is associated with surgery, dietary vitamin K deficiency, renal dysfunction, malignancy, and broad-spectrum antibiotic therapy...

Inhibition of Theophylline Clearance by Coadministered Ofloxacin Without Alteration of Theophylline Effects

Inhibition of Theophylline Clearance by Coadministered Ofloxacin Without Alteration of Theophylline Effects

Authors: Gregoire SL, Grasela TH, Freer JP, Tack KJ, Schentag JJ
Publication: Antimicrob Agents Chemother
Keywords: adolescent, adult, adverse effects, anti-infective agents, anti-infectives, blood, clinical pharmacology, drug effects, drug interactions, humans, infectious disease, kinetics, male, metabolic clearance rate, metabolism, ofloxacin, oxazines, pharmacology, plasma, pulmonology, research, research support, respiratory agents
Division: Clinical Pharmacology and Pharmacometrics (CPP)

The influence of multiple doses of ofloxacin (ORF 18489) on the disposition of theophylline was studied in 15 male volunteers. Subjects were confined in the Clinical Research Unit for 13 days and given a...

An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part I. Comparison of Methodologies

An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part I. Comparison of Methodologies

Authors: Grasela TH, Antal E, Townsend RJ, Smith RB
Publication: Clin Pharmacol Ther
Keywords: administration, adult, alprazolam, analysis, benzodiazepines, biological, blood, central nervous system agents, clinical trials, comparative study, computers, humans, kinetics, male, metabolism, methods, models, neurology, oral, pharmacokinetics, PKPD methodology, population, psychiatry, research support
Division: Clinical Pharmacology and Pharmacometrics (CPP)

NONMEM, a computer program that uses the method of extended least-squares analysis, has been advocated as a means of obtaining estimates of population pharmacokinetic parameters when only fragmentary...

Efficacy of Theophylline for Prevention of Post-Extubation Respiratory Failure in Very Low Birth Weight Infants

Efficacy of Theophylline for Prevention of Post-Extubation Respiratory Failure in Very Low Birth Weight Infants

Authors: Viscardi RM, Faix RG, Nicks JJ, Grasela TH
Publication: J Pediatr
Keywords: artificial, clinical trials, comparative study, etiology, humans, infant, intratracheal, intubation, low birth weight, newborn, pediatrics, physiopathology, positive-pressure respiration, prevention & control, pulmonology, random allocation, respiration, respiratory agents
Division: Clinical Pharmacology and Pharmacometrics (CPP)
Comparison of two pharmacokinetic techniques for individualizing factor VIII dosage in haemophilia patients

Comparison of two pharmacokinetic techniques for individualizing factor VIII dosage in haemophilia patients

Authors: Morfini M, Grasela TH, Longo G, Matucci M, Messori A, Vannini S, Rossi-Ferrini P
Publication: Haematologica
Keywords: blood, comparative study, Dose-Response Relationship, drug, Factor Viii, Hemophilia A, humans, kinetics, metabolic clearance rate, metabolism, research, therapeutic use, therapy
Division: Clinical Pharmacology and Pharmacometrics (CPP)
Safety of a higher loading dose of phenobarbital in the term newborn

Safety of a higher loading dose of phenobarbital in the term newborn

Authors: Donn SM, Grasela TH, Goldstein GW
Publication: Pediatrics
Keywords: adverse effects, Asphyxia Neonatorum, blood, drug therapy, half-life, humans, infant, newborn, pediatrics, phenobarbital, seizures, standards, therapeutic use
Division: Clinical Pharmacology and Pharmacometrics (CPP)

The conventional loading dose of phenobarbital for newborn infants with hypoxic-ischemic seizures, 20 mg/kg, often fails to control convulsive activity.

Neonatal Population Pharmacokinetics of Phenobarbital Derived from Routine Clinical Data

Neonatal Population Pharmacokinetics of Phenobarbital Derived from Routine Clinical Data

Authors: Grasela TH, Donn SM
Publication: Dev Pharmacol Ther
Keywords: AED, analysis, biological, birth weight, central nervous system agents, gestational age, half-life, humans, infant, kinetics, metabolism, models, neurology, newborn, P.H.S., pediatrics, pharmacokinetics, phenobarbital, population, premature, research support, therapy, U.S. Government
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Routine clinical pharmacokinetic (PK) data collected from 59 preterm infants who received phenobarbital were analyzed to estimate population PK parameters. Birth weights ranged from 600 to 3,620 g...

A calculator program for clinical application of the Bayesian method of predicting plasma drug levels

A calculator program for clinical application of the Bayesian method of predicting plasma drug levels

Authors: Ruffo S, Messori A, Grasela TH, Longo G, Donati-Cori G, Matucci M, Morfini M, Tendi E
Publication: Comput Programs Biomed
Keywords: administration & dosage, biological, blood, computers, drug therapy, Factor Viii, Hemophilia A, humans, kinetics, metabolism, Microcomputers, models, pharmaceutical preparations, plasma, population, Software
Division: Clinical Pharmacology and Pharmacometrics (CPP)

A pharmacokinetic program that allows individualization of drug dosage regimens through the Bayesian method is described.

Population Pharmacokinetics of Procainamide from Routine Clinical Data

Population Pharmacokinetics of Procainamide from Routine Clinical Data

Authors: Grasela TH, Sheiner LB
Publication: Clin Pharmacokinet
Keywords: analysis, arrhythmia, biological, cardiology, cardiovascular agents, congestive, drug therapy, female, heart, heart failure, humans, kinetics, male, metabolism, middle-aged, models, P.H.S., pharmacokinetics, plasma, population, procainamide, research support, therapeutic use, U.S. Government
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Routine clinical pharmacokinetic data collected from patients receiving procainamide were analysed to estimate population pharmacokinetic parameters. 116 plasma concentration determinations for procainamide...

Experience with NONMEM: Analysis of Routine Phenytoin Clinical Pharmacokinetic Data

Experience with NONMEM: Analysis of Routine Phenytoin Clinical Pharmacokinetic Data

Authors: Sheiner LB, Grasela TH
Publication: Drug Metab Rev
Keywords: AED, analysis, biological, central nervous system agents, computers, humans, kinetics, metabolism, methods, models, neurology, NONMEM, P.H.S., phenytoin, PKPD methodology, population, research support, U.S. Government
Division: Clinical Pharmacology and Pharmacometrics (CPP)

NONMEM, a program package the produces the extended least squares estimates of population parameters for a nonlinear mixed-effect model, has been applied to two data sets from patients routinely...

Steady-State Pharmacokinetics of Phenytoin from Routinely Collected Patient Data

Steady-State Pharmacokinetics of Phenytoin from Routinely Collected Patient Data

Authors: Grasela TH, Sheiner LB, Rambeck B, Boenigk HE, Dunlop A, Mullen PW, Wadsworth J, Richens A, Ishizaki T, Chiba K, Miura H, Minagawa K, Blain PG, Mucklow JC, Bacon CT, Rawlins M
Publication: Clin Pharmacokinet
Keywords: adolescent, adult, AED, analysis, biological, central nervous system agents, female, humans, kinetics, male, metabolism, models, NONMEM, pharmacokinetics, phenytoin, population, research support, U.S. Government
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Previously reported routine Phenytoin clinical pharmacokinetic data from Japan, England, and Germany were analysed to estimate population pharmacokinetic parameters. There were 780 steady-state…