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W-24 Population Pharmacokinetic-Pharmacodynamic Modeling and

Population Pharmacokinetic-Pharmacodynamic Modeling and Simulation of Neutropenia in Patients With. Advanced Cancer Treated With Palbociclib. Wan Sun1*, Diane Wang1. 1Clinical Pharmacology, Pfizer Oncology, Pfizer Inc, San Diego, CA, USA. Objectives: Neutropenia is the most common hematologic toxicity ...


Pharmacokinetic / Pharmacodynamic Modeling and Simulation of

Pharmacokinetic / Pharmacodynamic. Modeling and Simulation of Biomarker Response to. Venlafaxine and Sunitinib Administration. Dissertation zur Erlangung des Doktorgrades (Dr. rer. nat.) der Mathematisch- Naturwissenschaftlichen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn vorgelegt von. Andreas ...


Pharmacokinetic-pharmacodynamic modeling and simulation for

Pharmacokinetic–Pharmacodynamic Modeling and Simulation for Bactericidal Effect in an. In Vitro Dynamic Model. TAKAYUKI KATSUBE,1,2 YOSHITAKA YANO,1,3 YOSHINORI YAMANO,4 TADASHI MUNEKAGE,4. NAOMI KURODA,4 MIKIHISA TAKANO2. 1Biostatistics Department, Shionogi & Co., Ltd., Sagisu 5- 12-4, ...


Pharmacokinetic/Pharmacodynamic Modeling and Simulation of

Pharmacokinetic/Pharmacodynamic. Modeling and Simulation of Cefiderocol, a Parenteral Siderophore Cephalosporin, for Dose Adjustment Based on Renal. Function. Takayuki Katsube,a Toshihiro Wajima,a Toru Ishibashi,a. Juan Camilo Arjona Ferreira,b Roger Echolsb. Clinical Research Department, Shionogi & Co.,  ...


Introduction to Modeling and Simulation

MA/ST 810. Mathematical-Statistical Modeling and Analysis of Complex Systems. Introduction to Modeling and Simulation. • Introduction. • Pharmacokinetics and pharmacodynamics. • Modeling and simulation in drug development. • Modeling and simulation in design of a clinical trial – a case study. MA/ST 810 2009. 1 ...


Pharmacokinetic-Pharmacodynamic Modeling of Antibacterial Drugs

1086. Abstract——Pharmacokinetic-pharmacodynamic. (PKPD) modeling and simulation has evolved as an important tool for rational drug development and drug use, where developed models characterize both the typical trends in the data and quantify the variability in relationships between dose, concentration, and.


Novel Approaches to Mechanistic Pharmacokinetic

3 Towards Mechanistic Pharmacokinetic/Pharmacodynamic Modeling: Drug Interference with the ... Introduction. Modeling and simulation forms an integral part of various stages of drug discovery and development. ... A main drawback of empirical pharmacokinetic/pharmacodynamic modeling is its need for in vivo data that ...


Pharmacokinetic- Pharmacodynamic Modeling and Simulation

Я 2006 Springer Science+Business Media, Inc. All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer. Science+Business Media, Inc., 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or ...


Pharmacokinetic and pharmacodynamic modeling & simulation

Pharmacokinetic and pharmaco- dynamic modeling & simulation play a key role in throughout the drug development process, helping to generate hypotheses, interpret and understand experi- mental results and trial outcomes, to integrate available information and translate it to clinical implica- tions. Thus, modeling & ...


Semi-physiological pharmacokinetic–pharmacodynamic modeling

Mar 20, 2014 ... http://informahealthcare.com/xen. ISSN: 0049-8254 (print), 1366-5928 (electronic ). Xenobiotica, 2014; 44(9): 804–818 ! 2014 Informa UK Ltd. DOI: 10.3109/ 00498254.2014.900588. RESEARCH ARTICLE. Semi-physiological pharmacokinetic–pharmacodynamic modeling and simulation of 5-fluorouracil for  ...


Application of Population Pharmacokinetic and Pharmacodynamic

METRUM RESEARCH GROUP & METRUM INSTITUTE, 2012. Application of Population Pharmacokinetic and. Pharmacodynamic Modeling and Simulation. Marc R. Gastonguay, Ph.D. Scientific Director, Metrum Institute [email protected] metruminstitute.org. President & CEO, Metrum Research Group [email protected] metrumrg.com ...



Miller, R., Ewy, W., Corrigan, B. W., Ouellet, D., Hermann, D., Kowalski, K. G., … Lalonde, R. L. (2005). How Modeling and Simulation Have Enhanced Decision. Making in New Drug Development. Journal of Pharmacokinetics and Pharmacodynamics, 32(2), 185–197. Kimko, H., & Pinheiro, J. (2014). Model- based clinical ...


Use of statistical and pharmacokinetic–pharmacodynamic modeling

Use of statistical and pharmacokinetic–pharmacodynamic modeling and simulation to improve decision-making: A section summary report of the trends and innovations in clinical trial statistics conference. Holly Kimkoa, Seth Berryb, Michael OLKellyc, Nitin Mehrotrad, Matthew Hutmachere, and Venkat Sethuramanf. aGlobal ...


Pharmacokinetic–Pharmacodynamic Modeling of the Effectiveness

Data on the time course of the antinociceptive and respiratory depressant effect were analyzed on the basis of population logistic regression PK–PD models using non-linear mixed effects modeling software (NONMEM). The pharmacokinetics of buprenorphine and fentanyl were described by a three- and two-compartment ...


Population Pharmacokinetic-Pharmacodynamic Modeling and

Population Pharmacokinetic-Pharmacodynamic Modeling and. Simulation of Platelet Decrease Induced by Peg-interferon-alpha 2a. Tomohisa SAITO*, Satofumi IIDA and Takehiko KAWANISHI. Research Planning Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan. Full text of this paper is available at ...


Mechanism-based pharmacokinetic–pharmacodynamic modeling of

Abstract. Mathematical modeling of drug effects maximizes the information gained from an experiment, provides further insight into the mechanisms of drug effects, and allows for simulations in order to design studies or even to derive clinical treatment strategies. We reviewed modeling of antimicrobial drug effects and show ...


Pharmacokinetic–Pharmacodynamic Modeling and Simulation for in

Pharmacokinetic–Pharmacodynamic Modeling and. Simulation for In Vivo Bactericidal Effect in Murine. Infection Model. TAKAYUKI KATSUBE,1 YOSHINORI YAMANO,2 YOSHITAKA YANO1,3. 1Biostatistics Department, Shionogi & Co., Ltd., Sagisu 5-12-4, Fukushima-ku, Osaka 553-0002, Japan. 2Discovery Research ...


Mechanism-Based Pharmacokinetic–Pharmacodynamic Modeling

Mechanism-Based Pharmacokinetic–Pharmacodynamic Modeling of the Dopamine D2 Receptor Occupancy of Olanzapine in Rats. Authors ... PK-PD. pharmacokinetic and pharmacodynamic. Q. intercompartmental clearance. RSE. relative standard error. SSE. stochastic simulation and estimation. V1. volume of the central ...


A Mechanistic Pharmacokinetic/Pharmacodynamic Model of Factor

systemic pharmacokinetic-pharmacodynamic model of lampali- zumab in the .... PK/PD model of lampalizumab in a cynomolgus monkey to provide a ..... Model Simulations. A series of model simulations were performed using the estimated model parameters to examine the behavior of the drug and target in ocular tissue  ...


Bridging the Gap between Preclinical and Clinical Studies Using

Jun 1, 2012 ... antitumor efficacy to establish pharmacokinetic endpoints and predict active doses in the clinic. Experimental Design:A PK–PD model was used to characterize GDC-0973 tumor disposition andin vivo potency in WM-266-4 xenograft mice. Simulations were conducted using the PK–PD model along with.