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Pharmacokinetics analysis based on target-mediated drug distribution for RC18, a novel BLyS/APRIL fusion protein to treat systemic lupus erythematosus and rheumatoid arthritis.
Eur J Pharm Sci
April 2021
Clinical Pharmacology Research Center, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100032, China; Beijing Key Laboratory of Clinical PK & PD Investigation for Innovative Drugs, Pking Union Medical College Hospital, Beijing 100032, China. Electronic address:
Background And Purpose: RC18 is a novel recombinant fusion protein targeting on B lymphocyte stimulator (BLyS). We aimed to develop and qualify a population pharmacokinetics (PopPK) model for RC18 in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients, taking into account the mechanistic target-mediated drug disposition (TMDD) process.
Methods: A TMDD model of RC18 was developed using data from two phase I clinical trial (n = 23).