title: Implications of ICH-E5: Assessment of drug's sensitivity to ethnic factors and necessity of a bridging study for global drug development.
abstract: The ICH-E5 guideline provides a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective of minimizing duplication of clinical data, and it also describes the requirement of bridging studies for extrapolation of foreign clinical data to a new region. The ICH-E5 guideline brought great change in concept and strategy of global drug development for pharmaceutical companies. The procedures described in the ICH-E5 guideline have proved useful in the assessment of the ethnic sensitivity of a medicinal product that is to be introduced to a foreign region for registration purpose. Many companies are now developing various products based on ICH-E5 strategies and many successful cases will continuously appear within coming years.
authors.affiliation: Clinical Pharmacologist, Palam Vihar, Gurgaon, India.
authors.forename: Sandeep Kumar
authors.initials: SK
authors.lastname: Gupta