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Regulatory innovation for expansion of indications and pediatric drug development
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 devel...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Korean Society for Clinical Pharmacology and Therapeutics
2018
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6989250/ https://www.ncbi.nlm.nih.gov/pubmed/32055569 http://dx.doi.org/10.12793/tcp.2018.26.4.155 |