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A Comparison of the Pharmacokinetics and Pharmacodynamics of Pregabalin and Gabapentin
Pregabalin and gabapentin share a similar mechanism of action, inhibiting calcium influx and subsequent release of excitatory neurotransmitters; however, the compounds differ in their pharmacokineticExpand
Exposure‐Response Analysis in Patients With Schizophrenia to Assess the Effect of Asenapine on QTc Prolongation
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. In a parallel design,Expand
Changes in erythropoietin pharmacokinetics following busulfan-induced bone marrow ablation in sheep: evidence for bone marrow as a major erythropoietin elimination pathway.
The contribution of the bone marrow to in vivo erythropoietin (EPO) elimination was evaluated by determining EPO pharmacokinetic (PK) parameters in five adult sheep in a paired manner before andExpand
A pharmacodynamic analysis of erythropoietin-stimulated reticulocyte response in phlebotomized sheep.
The pharmacodynamics (PD) of the reticulocyte response resulting from phlebotomy-induced erythropoietin (EPO) was investigated in adult sheep. The anemia caused by the controlled phlebotomy (Hb < 4Expand
An Integrated Pharmacodynamic Analysis of Erythropoietin, Reticulocyte, and Hemoglobin Responses in Acute Anemia
AbstractPurpose. To determine by pharmacodynamic (PD) analysis physiologically relevant parameters of the cellular kinetics of erythropoiesis in acute anemia. Methods. The PD relationships amongExpand
Physiologically based and population PK modeling in optimizing drug development: A predict–learn–confirm analysis
Physiologically based pharmacokinetic (PBPK) modeling and classical population pharmacokinetic (PK) model‐based simulations are increasingly used to answer various drug development questions. In thisExpand
Performance Characteristics for Some Typical QT Study Designs Under the ICH E‐14 Guidance
The International Conference on Harmonization (ICH) guidance for clinical evaluation of QT prolongation (E14) affected drug development by advocating that a thorough QT study (TQT) be conductedExpand
Pharmacokinetic tracer kinetics analysis of changes in erythropoietin receptor population in phlebotomy‐induced anemia and bone marrow ablation
Objectives—The objective was to study in vivo erythropoietin (Epo) progenitor cell surface receptors (EpoR) in the bone marrow (BM) 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
An assessment of the effects of asenapine on QTc interval in patients with schizophrenia revealed a discrepancy between the results obtained by two different methods: an intersection–union test (IUT)Expand
Pharmacodynamic Analysis of the Microbiological Efficacy of Telithromycin in Patients with Community-Acquired Pneumonia
AbstractBackground and objective: Telithromycin, a ketolide antibacterial, demonstrates concentration-dependent bactericidal activity against the major pathogens causing community-acquiredExpand