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A Review and Assessment of Potential Sources of Ethnic Differences in Drug Responsiveness

From Wyeth Research, Collegeville, Pennsylvania (T. D. Bjornsson, D. Harper); Merck, Rahway, New Jersey (J. A. Wagner, K. Roman); Bristol-Myers Squibb, Princeton, New Jersey (S. R. Donahue, M. S. Khouri, D. S. Sonnichsen); Pharmacia, Peapack, New Jersey (A. Karim, D. J. Stalker); Pfizer, Groton, Connecticut (W. R. Murphy); AstraZeneca, Wilmington, Delaware (D. Schneck); Lilly, Singapore (S. D. Wise); PhRMA, Washington, DC (S. Dombey, C. Loew).

The International Conference on Harmonization (ICH) E5 guidelines were developed to provide a general framework for evaluating the potential impact of ethnic factors on the acceptability of foreign clinical data, with the underlying objective to facilitate global drug development and registration. It is well recognized that all drugs exhibit significant inter-subject variability in pharmacokinetics and pharmacologic response and that such differences vary considerably among individual drugs and depend on a variety of factors. One such potential factor involves ethnicity. The objective of the present work was to perform an extensive review of the world literature on ethnic differences in drug disposition and responsiveness to determine their general significance in relation to drug development and registration. A few examples of suspected ethnic differences in pharmacokinetics or pharmacodynamics were identified. The available literature, however, was found to be heterologous, including a variety of study designs and research methodologies, and most of the publications were on drugs that were approved a long time ago.

Key Words: Ethnic differences • drug development and registration • drug responsiveness • ICH E5 guidelines

Address for reprints: Thorir D. Bjornsson, MD, PhD, Clinical Pharmacology, Wyeth Research, 500 Arcola Road, Collegeville, PA 19426.

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