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

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. I...

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Veröffentlicht in:	Journal of clinical pharmacology 2003-09, Vol.43 (9), p.943-967
Hauptverfasser:	Bjornsson, Thorir D., Wagner, John A., Donahue, Stephen R., Harper, Dawn, Karim, Aziz, Khouri, Marlene S., Murphy, William R., Roman, Kristin, Schneck, Dennis, Sonnichsen, Daryl S., Stalker, Dennis J., Wise, Stephen D., Dombey, Stuart, Loew, Caroline
Format:	Artikel
Sprache:	eng
Schlagworte:	Biological and medical sciences Clinical Trials as Topic Continental Population Groups - statistics & numerical data Data Interpretation, Statistical Dose-Response Relationship, Drug Drug Approval Drug Design drug development and registration drug responsiveness Drug Therapy - standards Drug Therapy - statistics & numerical data Ethnic differences Female General pharmacology Guidelines as Topic Humans ICH E5 guidelines International Cooperation Male Medical sciences Miscellaneous Pharmacokinetics Pharmacology. Drug treatments
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