• Publications
  • Influence
A Comparison of the Pharmacokinetics and Pharmacodynamics of Pregabalin and Gabapentin
TLDR
Pregabalin appearsto have some distinct pharmacokinetic advantages over gabapentin that may translate into an improved pharmacodynamic effect, and may reduce pain comparably to the predicted maximum effect of gABapentin.
Exposure‐Response Analysis in Patients With Schizophrenia to Assess the Effect of Asenapine on QTc Prolongation
TLDR
An exposure‐response (E‐R) analysis using linear mixed effects modeling was conducted on data from a thorough QTc trial for asenapine in 148 patients with schizophrenia, predicting that the mean QTtcF increase was less than 5 milliseconds, the International Conference on Harmonisation—established threshold for clinical concern.
Changes in erythropoietin pharmacokinetics following busulfan-induced bone marrow ablation in sheep: evidence for bone marrow as a major erythropoietin elimination pathway.
TLDR
It is indicated that the bone marrow significantly contributes to the elimination of EPO in vivo.
Physiologically based and population PK modeling in optimizing drug development: A predict–learn–confirm analysis
TLDR
A model‐based approach can enable inclusion of patients with RI in phase 3 trials at appropriate doses, which may be an alternative to a dedicated RI study, or suggest that only a reduced‐size study in severe RI may be sufficient.
A pharmacodynamic analysis of erythropoietin-stimulated reticulocyte response in phlebotomized sheep.
TLDR
The pharmacodynamics of the reticulocyte response resulting from phlebotomy-induced erythropoietin (EPO) was investigated in adult sheep and supports the hypothesis that s.c. EPO dosing is more efficacious than i.v. therapeutic dosing.
An Integrated Pharmacodynamic Analysis of Erythropoietin, Reticulocyte, and Hemoglobin Responses in Acute Anemia
TLDR
Physiologically relevant cellular kinetics parameters can be obtained by an endogenous PK/PD analysis of phlebotomy data and are useful for elucidating the pathophysiologic etiology of various anemias.
Pharmacodynamic Analysis of the Microbiological Efficacy of Telithromycin in Patients with Community-Acquired Pneumonia
TLDR
Telithromycin exhibits near-maximal efficacy against three major pathogens causing CAP at a dose of 800mg once daily, and the probability of microbiological cure to be consistently greater than 90% over the observed range of predictor variables.
Performance Characteristics for Some Typical QT Study Designs Under the ICH E‐14 Guidance
TLDR
This report assesses the IUT false positive rate for 4 recently conducted TQT trials using simple simulation experiments and reveals significant limitations of the I UT with respect to excluding an effect and study interpretation for certain trial designs.
Pharmacokinetic tracer kinetics analysis of changes in erythropoietin receptor population in phlebotomy‐induced anemia and bone marrow ablation
TLDR
The objective was to study in vivo erythropoietin progenitor cell surface receptors (EpoR) in the bone marrow after phlebotomy and bone marrow ablation.
Comparison of QTc Data Analysis Methods Recommended by the ICH E14 Guidance and Exposure–Response Analysis: Case Study of a Thorough QT Study of Asenapine
TLDR
Results indicate that the IUT can produce biased estimates that may induce a high false‐positive rate in individual thorough QTc trials and support the use of E–R results as a basis for labeling.
...
...