Drug registration file prerequisites for European procedures;Le dossier pharmacocinétique des médicaments requis dans les procédures européennes

Annales Pharmaceutiques Francaises

Volumn 62, Issue 3, 2004, Pages 207-213

  Barre J ^a  

^a CENTRE HOSPITALIER INTERCOMMUNAL DE CRÉTEIL   (France)

Author keywords

Marketing approval; Pharmacokinetic prerequisites; Populations at risk; Posology; Summary of product characteristics

Indexed keywords

DRUG;

CONFERENCE PAPER; DOCUMENTATION; DRUG ABSORPTION; DRUG APPROVAL; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG ELIMINATION; DRUG METABOLISM; EUROPE; HIGH RISK POPULATION; HUMAN; PATHOPHYSIOLOGY; REGISTRATION;

EID: 3042745535     PISSN: 00034509     EISSN: None     Source Type: Journal    
DOI: 10.1016/s0003-4509(04)94304-0     Document Type: Conference Paper

References (19)

1. Directive 65/65/CEE du Conseil concernant le rapprochement des dispositions législatives, réglementaires et administratives, relatives aux spécialités pharmaceutiques. 25 janvier 1965.
2. Directive 75/318/CEE du Conseil relative au rapprochement des législations des États-membres concernant les normes et protocoles analytiques, toxico-pharmacologiques et cliniques en matière d'essais de spécialités pharmaceutiques. 20 mai 1975.
3. Directive 2001/83/CE du Parlement européen et du Conseil instituant un code communautaire relative aux médicaments à usage humain. 18 décembre 2001.
4. CPMP/EWP/2339/02 Concept paper on the development of a CPMP note for guidance on evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment.
5. CPMP/EWP/225/02 Concept paper on the development of a CPMP note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function.
6. CPMP/EWP/968/02 Concept paper on the development of a CPMP points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population.
7. CPMP/EWP/226/02 Concept paper on the development of CPMP note for guidance on the clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins.
8. CPMP/ICH/384/95 Topic S3A. Step 5. Note for guidance on toxicokinetics: a guidance for assessing systemic exposure in toxicology studies.
9. CPMP/ICH/385/95 Topic S3B Step 5. Note for guidance on pharmacokinetics: guidance for repeated dose tissue distribution studies.
10. CPMP/EWP/QWP/1401/98 Note for guidance on the investigation of bioavailability and bioequivalence.
11. CPMP/EWP/280/96 Note for guidance in modified release oral and transdermal dosage forms: section II (Pharmacokinetic and clinical evaluation).
12. CPMP/EWP/2655/99 Points to consider in pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products.
13. CPMP/602/95 Rev 3 Points to consider on the assessment of anti-HIV medicinal products.
14. CPMP/EWP/021/97 Points to consider on hormone replacement therapy.
15. CPMP/EWP/1343/01 Points to consider of new antifungal agents for invasive fungal infections.
16. Pharmacos. Eudralex volume 2. Pharmaceutical legislation: Notice to applicants. Vol 2B Presentation and content of the dossier.
17. CPMP/SWP/1042/99 Note for guidance on repeated dose toxicity.
18. Pharmacos. Eudralex volume 3. Medicinal products for human use: guidelines. Vol 3C Efficacy. 3CC3A: Pharmacokinetic studies in man.
19. Pharmacos. Eudralex volume 2. Pharmaceutical legislation: notice to applicants. Vol 2C Regulatory guidelines: Guideline on summary of product characteristics.