Table 4.
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