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The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies

Paper ID Volume ID Publish Year Pages File Format Full-Text
16561 42508 2009 8 PDF Available
Title
The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies
Abstract

Dose selection for first-in-human (FIH) clinical trials with monoclonal antibodies (mAbs) is based on specifically designed preclinical pharmacology and toxicology studies, mechanistic ex vivo/in vitro investigations with human and animal cells and pharmacokinetic/pharmacodynamic (PK/PD) modeling approaches and requires a thorough understanding of the biology of the target and the relative binding and pharmacological activity of the mAb in animals and humans. These investigations provide the essential information required for the selection of a safe starting dose and escalation for FIH trials based on toxicology and pharmacology data and the minimal anticipated biological effect level (MABEL) by integrating all available in vivo and in vitro data. In this review, strategies for estimation of the MABEL for mAbs specific for both membrane and soluble targets are presented and the scientific and regulatory challenges highlighted.

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The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies
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Publisher
Database: Elsevier - ScienceDirect
Journal: Current Opinion in Biotechnology - Volume 20, Issue 6, December 2009, Pages 722–729
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us