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. 2004 Nov;58(5):452–469. doi: 10.1111/j.1365-2125.2004.02228.x

Table 4.

Committee for Proprietary Medicinal Products (CPMP) and International Conference on Harmonization (ICH) regulatory guidelines relevant to the development of drugs in the elderly

1. CPMP Guidance on Pharmacokinetic Studies in Man*
2. ICH Note for Guidance on Dose Response Information to Support Drug Registration
3. CPMP Note for Guidance on the Investigation of Drug Interactions
4. ICH Note for Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data
5. ICH Note for Guidance on Studies in Support of Special Populations:
5a  Geriatrics
5b  Pharmacokinetics in renally or hepatically impaired patients
6. CPMP Note for Guidance on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Renal Function
7. CPMP Note for Guidance on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function
*

This guideline can be accessed on: http://pharmacos.eudra.org/F2/eudralex/vol-3/pdfs-en/3cc3aen.pdf All other guidelines can be accessed on: http://www.emea.eu.int/sitemap.htm