Model‐informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets

• Published in: Clinical and translational science Vol. 15; no. 2; pp. 297 - 308
• Main Authors: Munafo, Alain, Terranova, Nadia, Li, Dandan, Liu, Ping, Venkatakrishnan, Karthik
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01.02.2022; John Wiley and Sons Inc; Wiley
• Subjects: Asia - ethnology; Asian people; Biological Availability; Cell number; Cladribine; Cladribine - administration & dosage; Cladribine - pharmacokinetics; Clinical trials; Dosage; Dose-Response Relationship, Drug; Drug development; Drug dosages; Drug Interactions - ethnology; Drug therapy; Humans; Lymphocytes; Lymphocytes T; Multiple sclerosis; Patients; Pharmacodynamics; Pharmacokinetics; Phosphorylation; Population; Rare diseases; Review; Reviews; Sensitivity analysis; Tablets; Treatment Outcome; Asia; Hong Kong China; South Korea; Singapore; China; Taiwan

Cladribine tablets have been approved in many countries for the treatment of patients with various forms of relapsing multiple sclerosis (MS). Cladribine has a unique pharmacokinetic/pharmacodynamic (PK/PD) profile with a short elimination half‐life (~ 1 day) relative to a prolonged PD effect on spe...