Format

Send to

Choose Destination
Pharm Res. 2015 Nov;32(11):3584-92. doi: 10.1007/s11095-015-1742-y. Epub 2015 Jun 25.

An Introduction to the Regulatory and Nonclinical Aspects of the Nonclinical Development of Antibody Drug Conjugates.

Author information

1
ToxStrategies, Inc., Baltimore, MD, USA.
2
Applied BioMath, LLC., Winchester, MA, USA.
3
ToxStrategies, Inc., 70 SW Century Dr., Suite 100-409, Bend, OR, 97702, USA. bmounho-zamora@toxstrategies.com.

Abstract

Antibody drug conjugates (ADCs) are promising therapies currently in development for oncology with unique and challenging regulatory and scientific considerations. While there are currently no regulatory guidelines specific for the nonclinical development of ADCs, there are harmonized international guidelines (e.g., ICHS6(R1), ICHM3(R2), ICHS9) that apply to ADCs and provide a framework for their complex development with issues that apply to both small and large molecules. The regulatory and scientific perspectives on ADCs are evolving due to both the advances in ADC technology and a better understanding of the safety and efficacy of ADCs in clinical development. This paper introduces the key scientific and regulatory aspects of the nonclinical development of ADCs, discusses important regulatory and scientific issues in the nonclinical to clinical dose translation of ADCs, and introduces new concepts in the areas of pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation.

KEYWORDS:

antibody drug conjugate; nonclinical development; regulatory, toxicology

PMID:
26108879
DOI:
10.1007/s11095-015-1742-y
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center