Reports to the Food and Drug Administration's Adverse Drug Reaction Reporting System of prolonged prothrombin time due to a suspected interaction between warfarin sodium and a fluoroquinolone were…
An Evaluation of Point and Interval Estimates in Population Pharmacokinetics Using NONMEM Analysis
In a simulation study of the estimation of population pharmacokinetic parameters, including fixed and random effects, the estimates and confidence intervals produced by NONMEM were evaluated.
A Nationwide Survey of Antibiotic Prescribing Patterns and Clinical Outcomes in Patients with Bacterial Pneumonia
Antibiotic prescribing information was prospectively collected on 1822 hospitalized patients treated for suspected or documented bacterial pneumonia. Antibacterial therapy with a single antibiotic...
Prospective Surveillance of Intravenous Amphotericin B Use Patterns
Information on amphotericin B use patterns and infusion-related adverse events were prospectively collected from 397 hospitalized adults. The methods of initiating amphotericin B varied greatly, with the…
A Nationwide Survey of Prescribing Patterns for Thrombolytic Drugs in Acute Myocardial Infarction
In November 1988, 164 hospitals enrolled in the Drug Surveillance Network participated in a nationwide survey of prescribing patterns for thrombolytic drugs for patients with an acute myocardial infarction.
An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part III. Prospective Data Collection Versus Retrospective Data Assembly
The ability to estimate population pharmacokinetic parameters of alprazolam from fragmentary clinical data collected during clinical efficacy trials was evaluated in this series of studies. In the...
The Influence of Intravenous Cimetidine Dosage Regimens on the Disposition of Theophylline
The influence of the method of cimetidine administration on theophylline disposition was studied in nine healthy, cigarette smoking male volunteers. The treatment phases consisted of: A) theophylline...
Comparison of N-methylthiotetrazole dispositions in healthy volunteers following single intravenous doses of moxalactam, cefoperazone, and cefotetan
he N-methylthiotetrazole side chain (NMTT) that is present on several cephalosporins has been implicated in the development of antibiotic-associated hypoprothrombinemia.
Prospective Surveillance of Antibiotic-Associated Coagulopathy in 970 Patients
N-methyl-thio-tetrazole (NMTT) has been proposed as a causative factor in antibiotic-associated coagulopathy. To evaluate this hypothesis, a nationwide surveillance program was initiated to determine...
Inhibition of Enoxacin Absorption By Antacids or Ranitidine
Ten normal volunteers participated in a randomized, five-way crossover study to determine the effect of concurrent enoxacin and antacid or ranitidine administration on enoxacin absorption...
A Clinical Pharmacy-Oriented Drug Surveillance Network: Results of a Nationwide Antibiotic Utilization Review of Bacterial Pneumonia 1987
One hundred eighteen pharmacists enrolled in the Drug Surveillance Network completed a survey of antibiotic prescribing patterns for bacterial infections. A total of 319 hospitalized patients being...
The Population Pharmacokinetics of Theophylline in Neonates and Young Infants
The population pharmacokinetics of theophylline were evaluated using 391 theophylline serum concentration measurements from 108 neonates and young infants (postnatal age 0-26 weeks), who received...
Kinetics and Action of N-Methylthiotetrazole in Volunteers and Patients. Population-Based Clinical Comparisons of Antibiotics With and Without This Moiety
Normal volunteers and patients were studied to determine the relative importance of NMTT and patient risk factors in the production of hypoprothrombinemia. The normal volunteers demonstrated in vivo NMTT…
A Clinical Pharmacy-Oriented Drug Surveillance Network: II. Results of a Pilot Project
A nationwide network of clinical pharmacists has been organized for the purpose of collecting drug experience data generated during the routine clinical care of patients. In order to assess the utility...
A Clinical Pharmacy-Oriented Drug Surveillance Network: I. Program Description
The limitations of the new drug development process, particularly in regard to the evaluation of drug safety, have resulted in a need for monitoring drug experience in the postmarketing period. Although a...
An Evaluation of Population Pharmacokinetics in Therapeutic Trials. Part II. Detection of a Drug-Drug Interaction
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
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
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
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...