Role of pharmacokinetics in the development of medicinal products in the paediatric population - Scientific guideline
This document provides advice on the use of pharmacokinetic studies in paediatric drug development and on methodological issues concerning pharmacokinetic studies in paediatric patients.
Keywords: Children, extrapolation, dose finding, maturation, age, adolescents, newborns, infants, toddlers, pharmacokinetics
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Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population (PDF/114.35 KB)
Adopted
First published: 28/06/2006
Last updated: 28/06/2006
Legal effective date: 01/01/2007
EMEA/CHMP/EWP/147013/2004 -
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Overview of comments received on the draft guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population (PDF/193.34 KB)
First published: 21/09/2006
Last updated: 21/09/2006
EMEA/CHMP/EWP/246228/2006
- Clinical pharmacology and pharmacokinetics
- Scientific guidelines: paediatrics
- Directive 2001/83/EC
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Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party
- Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function
- ICH E3 Structure and content of clinical study reports
- ICH E6 (R1) Good clinical practice
- ICH E8 General considerations for clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- ICH Q2(R1) Validation of analytical procedures: text and methodology
- Investigation of chiral active substances
- Investigation of bioequivalence
- Investigation of drug interactions
- Pharmacokinetic and clinical evaluation of modified-release dosage forms
- Pharmacokinetic studies in man