Prostate cancer, acne, seborrhea, hirsutism, and androgenic alopecia are well recognized to depend upon an excess or increased sensitivity to androgens...
Phase III Population Pharmacokinetics And Pharmacodynamics Of Azimilide
Azimilide (AZ) is a class III antiarrhythmic drug being developed for the treatment of symptomatic atrial fibrillation/flutter (AF/FL) and/or symptomatic paroxysmal supraventricular tachycardia…
The Development of a Population Pharmacokinetic (PK) Model for Linezolid
Linezoid (lzd) is an oxazolidinone antibiotic under development for infection due to gram-positive bacteria. It is rapidly and extensively absorbed following oral administration and initial PK studies…
Characterization of the highly variable bioavailability of tiludronate in normal volunteers using population pharmacokinetic methodologies
Currently, the use of classical bioequivalence criteria is being called into question for certain classes of drugs such as bisphosphonates. These compounds typically possess a wide therapeutic index but may...
Applying epidemiology-based outcomes research to clinical decision-making A hypothetical model of biotechnology therapy in gram-negative sepsis
Sepsis occurs in a heterogeneous population. A prospective nationwide surveillance study found that populations stratified by infection type had significant differences in the incidence...
Population pharmacokinetics of tirilazad: effects of weight, gender, concomitant phenytoin, and subarachnoid hemorrhage
Data collected during Phase I and II in the development of tirilazad were pooled and analyzed using nonlinear mixed effects models to assess covariates which might affect tirilazad pharmacokinetics.
Population pharmacokinetics of lamotrigine adjunctive therapy in adults with epilepsy
Plasma concentrations of lamotrigine, an antiepileptic drug obtained in three adult controlled clinical trials conducted in the United States were pooled
Benchmarking And Risk Adjustment Of Patient Outcomes Across Anesthesia Provider Teams
In our current health care climate, it is becoming more common to compare patient outcome benchmarks across institutions and across providers within an institution. The JCAHO is mandating hospitals to…
Contributing Factors To Serious Adverse Outcomes
JCAHO is an accrediting body for hospitals in the United States. As part of the accreditation process, the JCAHO is initiating a new program called ORYX. The goal of the program is to integrate routinely…
An automated drug concentration screening and quality assurance program for clinical trials
The collection and analysis of drug concentration data collected during clinical trials is growing in popularity as a mechanism for explaining variability in patient outcomes.
Efficacy Of Bupropion Sr On Reducing Craving In Smoking Cessation
Bupropion HCl sustained release (Bup SR, ZybanTM) is the first non-nicotine treatment proven to be safe and effective for smoking cessation. Clinical studies have demonstrated that when used in…
Relationship between didanosine exposure and surrogate marker response in human immunodeficiency virus-infected outpatients
We used information available from routine clinic visits to characterize the pharmacokinetics of didanosine in 82 human immunodeficiency virus-infected patients.
Zalcitabine population pharmacokinetics: application of radioimmunoassay
Zalcitabine population pharmacokinetics were evaluated in 44 human immunodeficiency virus-infected patients (39 males and 5 females) in our immunodeficiency clinic.
Dose proportionality of cisatracurium
The dose proportionality of cisatracurium pharmacokinetics was assessed using a population approach by incorporating the collection of sparse...
Implementation of concentration dependent “first-pass” models using NONMEM
The development of drugs extensively metabolized by the P450 enzyme system may require the need to model concentration dependent 'first-pass' effects. This simulation study, performed using NONMEM…
Pharmacoepidemiology: a scientific basis for outcomes research
The discovery of fossils estimated to be about 550 million years old' and later, the interpretation of these fossils, forced a rethinking
Pretreatment regimens for adverse events related to infusion of amphotericin B
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...
Adverse drug reaction reporting in a multicenter surveillance study
To evaluate the performance of a multicenter, prospective surveillance program in identifying adverse events, and to seek explanations for misclassification bias.
Sepsis syndrome and associated sequelae in patients at high risk for gram negative sepsis
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...