Despite tremendous efforts to ensure the safety and effectiveness of newly marketed medications, a number of these have had significant problems after introduction of the drug to the market.
The initial clinical experience of 1819 physicians in maintaining anesthesia with propofol characteristics associated with prolonged time to awakening
In October 1989, propofol underwent Phase IV Food and Drug Administration testing that involved 25,981 patients, 1722 institutions, and 1819 anesthesiologists. Participants were 18-80 yr of age and ASA physical status I-III...
Hemodynamic effects of propofol: data from over 25,000 patients
To investigate clinically important hypotension and bradycardia after induction of anesthesia with propofol, we analyzed data from a Phase IV stepwise study involving 25,981 patients, 1722 institutions, and 1819 anesthesiologists. In Step 1, propofol was used for...
The clinical evaluation of new drugs for sepsis A prospective study design based on survival analysis
To develop a survival model and severity assessment method to estimate the 28-day mortality risk for patients with sepsis syndrome entering phase 2 and 3 drug evaluations.
Adverse events in a multicenter phase IV study of propofol: evaluation by anesthesiologists and postanesthesia care unit nurses
Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug.
Phase IV study of propofol: validation of the data set
In 1989-1990, Stuart Pharmaceuticals conducted a Phase IV study of propofol on over 26,000 patients, later making the large data base available to a team of epidemiologists and anesthesiologists for analysis.
How do anesthesiologists select patients when introducing a new drug into practice
As part of the marketing strategy for the anesthetic drug propofol (Diprivan), Stuart Pharmaceuticals began a Phase IV postmarketing study soon after the drug received Food and Drug Administration approval in 1989.
Predictive performance of population pharmacokinetic parameters of tianeptine as applied to plasma concentrations from a post marketing study
The predictive ability of population pharmacokinetic parameters of tianeptine, obtained from a mixed effect analysis of pre-marketing pharmacokinetic studies, was evaluated using tianeptine plasma...
Capability of hospital computer systems in performing drug use evaluations and adverse drug event monitoring
A survey to determine the extent of computerization in key areas of hospitals, the information being collected in the databases, and the capabilities of the computer systems for performing adverse drug event...
Evaluation of population pharmacokinetics in therapeutic trials. IV. Application to postmarketing surveillance
The feasibility of incorporating blood sampling for population pharmacokinetic analysis into postmarketing surveillance was evaluated.
Development of a population pharmacokinetic database for tianeptine
Two thousand three hundred and thirty five plasma concentrations of tianeptine from 112 patients enrolled in nine studies of tianeptine pharmacokinetics performed prior to the marketing of the drug were...
Population pharmacodynamics of doxacurium
The nonlinear mixed-effects modeling (NONMEM) computer program was used to investigate the variability in the duration of doxacurium-induced neuromuscular block in 408 patients enrolled in phase II and phase III clinical trials of doxacurium. Spontaneous...
Evaluation of hypothesis Testing for comparing two populations using NONMEM analysis
In a simulation study of inference on population pharmacokinetic parameters, two methods of performing tests of hypotheses comparing two populations using NONMEM were evaluated. These two methods are the test based upon 95% confidence intervals...
Changes in prescribing patterns in long-term care facilities and impact on incidence of adverse events
The addition of benzodiazepines to the triplicate prescription program in New York State was successful in reducing the use of benzodiazepines in a nursing home population, but the use of alternative agents was substantially increased. The reduction in...
Impact of triplicate prescription program on psychotropic prescribing patterns in long-term care facilities
To assess the impact of the effect of the New York state triplicate prescription program on psychotropic prescribing patterns in selected long-term care facilities over a one-year period.
An evaluation of the quinolone theophylline interaction using the Food and Drug Administration spontaneous reporting system
A review of the Food and Drug Administration's spontaneous reporting system identified 48 reports of adverse events in patients who received concomitant therapy with ciprofloxacin (n = 39) or norfloxacin (n = 9) and theophylline. The mean (SD) age of these cases...
Population pharmacokinetic analysis of didanosine (2′,3′-dideoxyinosine) plasma concentrations obtained in phase I clinical trials in patients with AIDS or AIDS related complex
Plasma didanosine concentration data from 36 patients receiving once-a-day therapy and from 33 patients receiving twice-a-day therapy were subject to population pharmacokinetic analysis with the computer program NONMEM. Once- or twice-a-day regimens of...
A nationwide investigation of a possible protamine drug product defect
To follow-up a report submitted to FDA Spontaneous Reporting System, we investigated the hypothesis that there was not a striking increase in unexpected deaths within four hours after elective coronary artery bypass surgery associated with protamine sulfate use.
Prospective evaluation of risk factors for antibiotic associated bleeding in critically ill patients
A prospective surveillance program was initiated to determine the relative role of antibiotics containing N-methylthiotetrazole (NMTT) versus patient risk factors in producing antibiotic-associated bleeding. Five hundred forty-six critically ill patients with serum albumin 30...
A nationwide survey of clinical laboratory methodologies for fungal infections
Many hospitalized patients are at risk for fungal infections. In order to characterize present clinical laboratory experience and facilities for diagnosis and management...