A5061380807- Statistical Methods in Clinical Trials
- Pharmaceutical studies and practices
- Health Systems, Economic Evaluations, Quality of Life
- Pharmacogenetics and Drug Metabolism
- Pharmaceutical Economics and Policy
- Antibiotics Pharmacokinetics and Efficacy
- Advancements in Transdermal Drug Delivery
- Biosimilars and Bioanalytical Methods
- Effects and risks of endocrine disrupting chemicals
- Blood transfusion and management
- Computational Drug Discovery Methods
- Biomedical Ethics and Regulation
- Cancer Treatment and Pharmacology
- Advanced Causal Inference Techniques
- Pharmaceutical Practices and Patient Outcomes
- Pharmaceutical industry and healthcare
- Neonatal Health and Biochemistry
- Drug Transport and Resistance Mechanisms
- Analytical Methods in Pharmaceuticals
- Hemodynamic Monitoring and Therapy
- Advanced Drug Delivery Systems
- Systemic Lupus Erythematosus Research
- Platelet Disorders and Treatments
- Contact Dermatitis and Allergies
- Monoclonal and Polyclonal Antibodies Research
DGA Partners
2014-2025
University of California, San Francisco
2007-2024
Texas A&M University
2014
University of Alabama at Birmingham
2014
Fast Track Drugs and Biologics
2014
Washington Center
2006-2012
Georgetown University
1996-2005
Georgetown University Medical Center
1995-2003
University of Auckland
2000-2003
Amgen (United States)
2003
Clinical Pharmacology and Therapeutics (1992) 51, 465–473; doi:10.1038/clpt.1992.47
Two international meetings were convened in 1998 to review the current science of drug development and potential opportunities optimize evaluation new drugs humans. This report represents a synopsis these meetings, focuses on state knowledge pertaining development, future scientific technical needs, relative merits various strategies intended accelerate clinical drugs.
Abstract Purpose Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality pre‐marketing development, regulatory review, surveillance. We documented FDA‐approved new molecular entities (NMEs), investigated trends over time across therapeutic groups, on premise that drug development methods have yielded fewer time. Methods compiled a list NMEs approved FDA from 1...
A 2-day workshop on "Physiologically Based Pharmacokinetics (PBPK) in Drug Development and Regulatory Science" came to a successful conclusion May 30, 2002, Washington, DC. More than 120 international participants from the environmental predominantly pharmaceutical industries, Food Administration (FDA), universities attended this workshop, organized by Center for Science, Georgetown University, The first of its kind specifically devoted subject, intensive comprising 7 plenary presentations...
Although human toxicity from exposure to the plasticizer di(2-ethylhexyl) phthalate (DEHP) is unknown, reports of animal DEHP have stimulated extensive toxicological studies. In absence direct data, information on disposition and metabolism in primates man may enhance our assessment toxic potential man. Studies African Green monkey show that compound rapidly extensively metabolized. It excreted largely urine (greater than 90%) as conjugated (glucuronide) oxidation products mono(2-ethylhexyl)...
In 42 patients requiring digitalis, and randomly divided into two groups, the performance of a computer program using patient size renal function to compute digoxin dosage was compared that unaided physician judgment. Serum concentrations were measured repeatedly. Efficacy by changes in manifestations heart failure, toxicity electrocardiographic criteria. For each patient, physicians specified desired serum concentration predicted this at visit. one group, suggested needed achieve...
Objective Our objective was to develop a population pharmacokinetic and pharmacodynamic model of etanercept in patients with rheumatoid arthritis, the American College Rheumatology response criterion 20% improvement (ACR20) used as binary clinical outcome variable. Methods Concentration-time profiles from 25 subjects, administered mg subcutaneous twice weekly for 24 weeks, were pooled data 77 enrolled 24-week, randomized, double-blind study comparing 50 weekly. The cumulative area under...
The renal clearances of digoxin, creatinine, and urea nitrogen were determined simultaneously in each 41 patients receiving most whom there was prerenal azotemia. Mean ± SD values were: blood (RUN), 26.1 12.8 mg per 100 ml; 1.1 + 0041 creatinine clearance, 78 42 ml/min/1.73 m 2 ; digoxin 66.6 42.1 27.8 19.2 . Correlation analysis revealed that clearance is superior to RUN serum concentration the degree relationship clearance. Moreover, using partial correlation techniques, it apparent these...
Approval of the new anticoagulant preservative, CPDA‐1, was based in part on data from human clinical trials CPDA‐1 performed by six cooperating laboratories and two blood bag manufacturers. Biochemical red cell survival properties 123 units stored for 28 to 35 days (as reported laboratories) are briefly summarized.
This study was performed to estimate the population pharmacokinetic (PK) parameters of etanercept in pediatric juvenile rheumatoid arthritis (JRA) patients and compare steady‐state time‐concentration profiles between 0.8‐mg/kg once‐weekly 0.4‐mg/kg twice‐weekly subcutaneous (SC) regimens by clinical trial simulation. To this end, mixed‐effect analysis (NONMEM, Version 5.1) using PK database consisting 69 JRA (4–17 years). Based on obtained herein, a Monte Carlo simulation experiment...