Considerations on nonclinical pharmacology and toxicology studies of antibody-drug conjugates for oncology
YAN Li-ping
WANG Hai-xue
WANG Qing-li
Abstract：Antibody-drug conjugates (ADCs) as anti-cancer agents are designed to improve the therapeutic index of the cytotoxin by specifically delivering cytotoxin to tumor cells.The development path for ADCs is more complex and challenging than for unmodified antibodies or cytotoxin.This paper presents primary considerations on the nonclinical pharmacology,toxicology and pharmacokinetic studies of ADCs,mainly based on ICH S6 and ICH S9 guidelines.
Keywords：antibody-drug conjugatesantibodycytotoxinoncologynonclinical pharmacology and toxicology studies
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1894-1899 )