Ethnic Bridging

People of Asian descent can metabolize drugs differently than others. Therefore, Asian regulatory authorities may require absorption, distribution, metabolism, and excretion (ADME) data in Asian subjects before a drug is approved for marketing. Clinilabs’ Phase I units are located in regions that are home to the largest Asian population in the US who meet standard criteria for bridging studies, making them the world’s leading destinations for single- or multi-center Ethnic Bridging trials.

Subjects

  • Japanese healthy volunteers and patients
  • Chinese healthy volunteers and patients
  • Access to other Asian populations including those of Thai, Indian, and Korean descent

Special Accommodations

  • Cultural accommodations
  • Multilingual staff
  • Foreign language translations of study documents

TQT Studies

When TQT studies are required in Japanese subjects, the option of conducting these studies in the US is now available.  Although it is not expected that the results of a thorough QT/QTc study will be affected by ethnic factors, data is limited, and there may be situations in which Japanese data is preferred.  Clinilabs offers access to the latest, continuous 12-lead Holter telemetry system for use in TQT studies, and access to Japanese subjects in the Northeast.

 

 

Click HERE to download our Ethnic Bridging Case Study.