Simulations Plus

The discovery of fossils estimated to be about 550 million years old' and later, the interpretation of these fossils, forced a rethinking

Infusion-related adverse events (IRAEs) such as nausea, vomiting, fever, chills, and thrombophlebitis that are associated with amphotericin B therapy often lead clinicians to prescribe a number of adjunctive pretreatment medications...

To evaluate the performance of a multicenter, prospective surveillance program in identifying adverse events, and to seek explanations for misclassification bias.

We conducted a prospective surveillance study of 80 hospitals across the United States to determine the incidence of sepsis syndrome and its associated sequelae in hospitalized patients over age 18 years who...

Phase I dose-escalating trials of didanosine revealed dose-limiting toxicities, including pancreatitis, and established a total daily dose of 12.5 mg/kg/day as the maximum tolerated dose.

To describe the incidence of acute renal insufficiency and identify potential risk factors associated with this adverse medical event.

To evaluate the prescribing patterns of antifungal agents in the hospital setting after the introduction of fluconazole, a new broad-spectrum bis-triazole antifungal agent.

During propofol-nitrous oxide (N2O) anesthesia, volatile anesthetics are frequently administered to treat signs of inadequate anesthesia and to decrease the possibility of intraoperative awareness.

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.

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...

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...

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.

Phase II and III studies are tightly controlled trials investigating adverse effects before government approval of a new drug.

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.

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.

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...

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...

The feasibility of incorporating blood sampling for population pharmacokinetic analysis into postmarketing surveillance was evaluated.