Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.
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Early phase clinical trials to identify optimal dosing and safetyReceptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical developmentAgonistic TAM-163 antibody targeting tyrosine kinase receptor-B: applying mechanistic modeling to enable preclinical to clinical translation and guide clinical trial designGetReal in mathematical modelling: a review of studies predicting drug effectiveness in the real world.Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodiesDeveloping the next generation of monoclonal antibodies for the treatment of rheumatoid arthritis.From target selection to the minimum acceptable biological effect level for human study: use of mechanism-based PK/PD modeling to design safe and efficacious biologics.Applications of human pharmacokinetic prediction in first-in-human dose estimationPredicting the F(ab)-mediated effect of monoclonal antibodies in vivo by combining cell-level kinetic and pharmacokinetic modellingExposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection.Modeling, simulation, and translation framework for the preclinical development of monoclonal antibodiesDetermination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013Biotherapeutic first-in-human dose selection: making use of preclinical markers.Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development?Bioanalysis of target biomarker and PK/PD relevancy during the development of biotherapeutics.Optimized nonclinical safety assessment strategies supporting clinical development of therapeutic monoclonal antibodies targeting inflammatory diseases.Tools for predicting the PK/PD of therapeutic proteins.Pharmacology-based toxicity assessment: towards quantitative risk prediction in humans.AFIR: A Dimensionless Potency Metric for Characterizing the Activity of Monoclonal Antibodies.Whither pharmacometrics?: present state and future choices.Non-Clinical Pharmacokinetics, Prediction of Human Pharmacokinetics and First-in-Human Dose Selection for CNTO 5825, an Anti-Interleukin-13 Monoclonal Antibody.Pharmacology 2.0.Estimation of Maximum Recommended Therapeutic Dose Using Predicted Promiscuity and Potency.A Tutorial on Target-Mediated Drug Disposition (TMDD) Models.Mechanistic Projection of First-in-Human Dose for Bispecific Immunomodulatory P-Cadherin LP-DART: An Integrated PK/PD Modeling Approach.Integrating data from the IMPD/IB. A new tool for translational integration of preclinical effects.Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction.Applying physiological and biochemical concepts to optimize biological drug development.
P2860
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P2860
Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics.
description
article científic
@ca
article scientifique
@fr
articolo scientifico
@it
artigo científico
@pt
bilimsel makale
@tr
scientific article published on 11 December 2008
@en
vedecký článok
@sk
vetenskaplig artikel
@sv
videnskabelig artikel
@da
vědecký článek
@cs
name
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@en
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@nl
type
label
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@en
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@nl
prefLabel
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@en
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@nl
P2860
P1476
Use of pharmacokinetic/ pharma ...... trials of high-risk biologics.
@en
P2093
Balaji M Agoram
P2860
P304
P356
10.1111/J.1365-2125.2008.03297.X
P407
P577
2008-12-11T00:00:00Z