How to optimise drug study design: pharmacokinetics and pharmacodynamics studies introduced to paediatricians.
J Pharm Pharmacol
; 69(4): 439-447, 2017 Apr.
Article
em En
| MEDLINE
| ID: mdl-27671925
ABSTRACT
OBJECTIVES:
In children, there is often lack of sufficient information concerning the pharmacokinetics (PK) and pharmacodynamics (PD) of a study drug to support dose selection and effective evaluation of efficacy in a randomised clinical trial (RCT). Therefore, one should consider the relevance of relatively small PKPD studies, which can provide the appropriate data to optimise the design of an RCT.METHODS:
Based on the experience of experts collaborating in the EU-funded Global Research in Paediatrics consortium, we aimed to inform clinician-scientists working with children on the design of investigator-initiated PKPD studies. KEYFINDINGS:
The importance of the identification of an optimal dose for the paediatric population is explained, followed by the differences and similarities of dose-ranging and efficacy studies. The input of clinical pharmacologists with modelling expertise is essential for an efficient dose-finding study.CONCLUSIONS:
The emergence of new laboratory techniques and statistical tools allows for the collection and analysis of sparse and unbalanced data, enabling the implementation of (observational) PKPD studies in the paediatric clinic. Understanding of the principles and methods discussed in this study is essential to improve the quality of paediatric PKPD investigations, and to prevent the conduct of paediatric RCTs that fail because of inadequate dosing.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Papel do Médico
/
Projetos de Pesquisa
/
Preparações Farmacêuticas
/
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Pediatras
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Child
/
Humans
Idioma:
En
Revista:
J Pharm Pharmacol
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Holanda