Regulatory aspects of pharmacokinetic profiling in special populations: A European perspective

Clinical Pharmacokinetics

Volumn 47, Issue 11, 2008, Pages 693-701

  Edholm, Monica ^a   Gil Berglund, Eva ^a   Salmonson, Tomas ^a  

^a MEDICAL PRODUCTS AGENCY   (Sweden)

Author keywords

Elderly; Ethnic groups; European medicines agency; Gender differences; Kidney disorders; Liver dysfunction; Pharmacokinetics; Regulatory process

Indexed keywords

ORAL CONTRACEPTIVE AGENT;

CLINICAL PROTOCOL; CLINICAL TRIAL; DATA ANALYSIS; DRUG APPROVAL; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG EXPOSURE; DRUG INDICATION; DRUG RESEARCH; DRUG SAFETY; DRUG UTILIZATION; EUROPE; HUMAN; KIDNEY DYSFUNCTION; LIVER DYSFUNCTION; METHODOLOGY; NOTE; PARAMETER; PATIENT MONITORING; PATIENT SELECTION; PHARMACODYNAMICS; PHARMACOKINETICS; PHASE 3 CLINICAL TRIAL; POPULATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SAMPLING;

DRUG ADMINISTRATION SCHEDULE; DRUG AND NARCOTIC CONTROL; EUROPE; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; PRACTICE GUIDELINES AS TOPIC;

EID: 53549128677     PISSN: 03125963     EISSN: 03125963     Source Type: Journal    
DOI: 10.2165/00003088-200847110-00001     Document Type: Note

References (9)

1. European Medicines Agency. Note for guidance: pharmacokinetic studies in man [no. 3CC3A; online]. Available from URL: http://www.emea.europa.eu/pdfs/ human/ewp/3cc3aen.pdf [Accessed 2008 Aug 28]
2. European Medicines Agency Committee for Medicinal Products for Human Use. Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function [no. CHMP/EWP/225/02; online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/022502en.pdf [Accessed 2008 Aug 28]
3. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function [no. CPMP/EWP/2339/02; online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/233902en.pdf [Accessed 2008 Aug 28]
4. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population [no. CHMP/EWP/147013/04; online]. Available from URL: http://www.emea.europa.eu/pdfs/human/ewp/14701304en.pdf [Accessed 2008 Aug 28]
5. European Medicines Agency Committee for Medicinal Products for Human Use. Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products [no. EMEA/128517/2006; online]. Available from URL: http://www.emea.europa.eu/pdfs/human/pharmacogenetics/12851706enfin.pdf [Accessed 2008 Aug 28]
6. European Medicines Agency Committee for Proprietary Medicinal Products. Note for guidance on studies in support of special populations: geriatrics [no. CPMP/ICH/379/95; online]. Available from URL: http://www.emea.europa.eu/pdfs/ human/ich/037995en.pdf [Accessed 2008 Aug 28]
7. European Medicines Agency Committee for Proprietary Medicinal Products. Note for guidance on ethnic factors in the acceptability of foreign clinical data (no. CPMP/ICH/289/95; online]. Available from URL: http://www.emea.europa. eu/pdfs/human/ich/028995en.pdf [Accessed 2008 Aug 28]
8. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on reporting the results of population pharmacokinetic analyses [no. CHMP/EWP/185990/06; online]. Available from URL: http://www.emea.europa.eu/pdfs/ human/ewp/18599006enfin.pdf [Accessed 2008 Aug 28]
9. Bergquist C, Lindegård J, Salmonson T. Dosing recommendations in liver disease. Clin Pharmacol Ther 1999 Aug; 66 (2): 201-4