Regulatory innovation for expansion of indications and pediatric drug development
Translational and Clinical Pharmacology
;
: 155-159, 2018.
Artigo
em Inglês
| WPRIM
| ID: wpr-742421
ABSTRACT
For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Armazenamento e Recuperação da Informação
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Criança
/
Humanos
Idioma:
Inglês
Revista:
Translational and Clinical Pharmacology
Ano de publicação:
2018
Tipo de documento:
Artigo
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