An effective dosing regimen of b-lactam and macrolide antibiotics for otitis media involving S. pneumoniae (SP) requires that drug concentrations in middle ear fluid (MEF) remain above the MIC (T>MIC)…
Factors Influencing The Pharmacokinetics (Pk) Of The Anticancer Drug Irinotecan (Cpt-11) And Its Major Metabolites, Sn-38 And Sn-38g
To evaluate significant covariate effects on the PK of CPT-11 (C), SN-38 (S) and SN-38G (G).
Population Pharmacokinetics (PK) Of Linezolid In Neonates And Young Infants
Linezolid (LZD) is the first approved oxazolidinone antibiotic and has shown broad activity against gram-positive bacteria, including VRE and MRSA. Previous studies indicated LZD clearance was higher in…
Population Pharmacodynamic Assessment of Atazanavir Exposure, Uridine Diphosphate-Glucuronosyl Transferase (UGT) 1A1 Genotype and Safety in Healthy Subjects
Atazanavir (BMS-232632) is a potent HIV-protease inhibitor with a favorable resistance profile in vitro. Dose-related elevations of total bilirubin (primarily unconjugated) have been observed with…
A New Paradigm of Real-Time Data Assembly to Support Knowledge-Based Decision Making: A Case Study
Real-time data assembly (RTDA) to support knowledgebased decision making was implemented for the development of a compound during Phase II. Program goals were to develop a data warehouse to expedite…
Comparison of Post-Operative Nosocomial Infection Associated with Blood Management Techniques in Cardiovascular and Orthopedic Surgery
Numerous risks are associated with allogeneic blood transfusions, however non-allogeneic blood options can minimize the use of allogeneic blood. This study compared infection rates associated with blood…
Simultaneous Population Pharmacokinetic (PBK) Modeling of Irinotecan (CPT-11) and its Major Metabolites, SN 38 and SN-38G
To develop a PPK model in NONMEM® that simultaneously predicts the plasma concentration (Cp) profiles of CPT-11 (C) and its metabolites, SN-38 (S) and SN-38G (G).
Uniqueness of Solutions to Compartmental Models of Population Pharmacokinetics for Drugs Undergoing Complex Metabolism
To investigate parameter identifiability and uniqueness of solutions to compartmental population pharmacokinetic (PPK) models for drugs with complex metabolism.
Comparison of Laboratory Safety Data from Japanese and Non-Japanese in Linezolid Phase I Studies
The laboratory safety data of linezolid (lzd) pooled from 6 multi-dose Phase I studies were compared in 65 Japanese (J) and 56 non-Japanese (non-J) subjects.
Comparison of Linezolid Pharmacokinetics from Phase I Studies of Japanese and Caucasians
This bridging analysis compared pharmacokinetic (PK) parameters for linezolid (lzd) observed in Japanese (J) and Caucasians (C) in traditional PK Phase I studies.
Population Modeling to Guide Phase 3 Dose Selection for AC2993 (Synthetic Exendin-4)
AC2993 is a novel glucose lowering agent for the treatment of patients with type 2 diabetes.
Population Pharmacodynamic (PD) Assessment of the Safety and Antiretroviral Activity of Atazanavir (BMS-232632)
Atazanavir (BMS-232632), currently in Phase III development, is a well-tolerated, once-daily protease inhibitor (PI) which does not appear to elevate cholesterol or triglyceride blood levels and has…
Population Pharmacokinetics/Pharmacodynamics of Antidepressant R,R(-) and S,S(+) Reboxetine (RBX)
To develop a population pharmacokinetic model describing the disposition of each enantiomer of antidepressant reboxetine and a pharmacodynamic model relating plasma concentrations and adverse effects.
A New Paradigm in Pediatric Drug Development: The Application of Cognitive Engineering
Design of clinical trials in pediatrics is complicated by sensitive ethical considerations, a small pool of appropriate study subjects, and difficulty in determining drug dosing regimens. Cognitive engineering…
Transcend Global and Corporate Boundaries During Drug Development
We developed an innovative and alternative web-based strategy which combines a hypertext environment with human intelligence and creativity to lead a scientific audience through complex statistical…
Integrating Real-Time Data Assembly (RTDA) and Population Pharmacokinetics as Tactical Components of Cognitive Engineering
The goal of drug development is to produce a safe and efficacious drug that will thrive in a competitive marketplace. Cognitive engineering couples technology and human intelligence to generate and use…
The Role of Population PK/PD Analysis During the Implementation of a Bridging Strategy for Linezolid
To describe the population PK/PD analysis process to support a bridging strategy for regulatory approval of Linezolid in Japan/Asia Pacific region.
Internet Based Communication Strategies to Support Linezolid Bridging Programs During Global Drug Development
To describe an Internet based communication strategy to facilitate scientific collaboration during the Linezolid global drug development program.
Integration of Pharmaceutical Product Development in Asia/Japan Into the Global Program
With increasing global acceptance of the provisions in various guideline documents resulting from the International Conferences on Harmonization (ICH) and the advent of regulatory changes in Asia Pacific…
Influence of Dose Size on Dose Response Relationships for Linezolid Efficacy Using Monte Carlo Simulations
Phase II linezolid (LZD) data analyses suggested that AUC0-24/MIC ratio was an important predictor of efficacy outcome. Monte Carlo simulations were performed to determine whether dose size…