A Simple Method for the Prediction of Human Concentration-Time Profiles and Pharmacokinetics of Antibody-Drug Conjugates (ADC) from Rats or Monkeys.

ABSTRACT: Knowledge of human concentration-time profiles from animal data can be useful during early drug development. The objective of this study is to predict human concentration-time profiles of antibody-drug conjugates (ADCs) and subsequently predict pharmacokinetic parameters in humans from rats or monkeys. Eight methods with different exponents of volume of distribution (0.8-1) as well as exponents of clearance (0.85), along with the exponents of volume of distribution for 5 ADCs, were used to predict human concentration-time profiles. The PK parameters were also scaled to humans from monkeys or rats using fixed exponents and compared with the PK parameters predicted from predicted human concentration-time profiles. The results of the study indicated that the exponent 0.9 and the combination o

SUBMITTER: Mahmood I 

PROVIDER: S-EPMC9219807 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature