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BMJ 2006;332:1393 (10 June), doi:10.1136/bmj.332.7554.1393
| The first 150 words of the full text of this article appear below. |
EDITORMcDowell et al conclude that patients from different ethnic groups have different risks for important adverse drug reactions on the basis of a meta-analysis of adverse reactions due to drugs used in cardiovascular medicine.1 Data are sparse, and regulators should ask for better data before licensing.
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The use of pharmacokinetic and pharmacodynamic modelling would greatly facilitate this process. The European Commission sponsored a workshop to facilitate the incorporation of such modelling studies into drug development. Data from 1997 on naratriptan, a serotonin agonist treatment for acute migraine, used a population approach and Bayesian predictions to examine the pharmacokinetic and pharmacodynamic relations for oral naratriptan during phase II clinical trials.2 Hepatic clearance of naratriptan declined with age and use of hormone contraception, potentially increasing the likelihood of adverse events leading to product labelling restrictions for elderly patients and leading to higher efficacy in women.3 In tobacco smokers and black
David S Millson, general practitioner principal
Leek Health Centre, Leek ST13 6JB david.millson@tiscali.co.uk