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An agency of the European Union
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PPHN - clinical vs regulatory needs Marek Migdal MD, PhD Deputy - - PowerPoint PPT Presentation
PPHN - clinical vs regulatory needs Marek Migdal MD, PhD Deputy - - PowerPoint PPT Presentation
PPHN - clinical vs regulatory needs Marek Migdal MD, PhD Deputy Head of PICU, Childrens Memorial Health Institute Warsaw, Poland Member of the PDCO EMA An agency of the European Union 2 Ru-Jeng Teng et al. ( Journal of the Form osan
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Ru-Jeng Teng et al. ( Journal of the Form osan Medical Association, 2 0 1 3 )
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Vorhies EE, I vy DD. Drug Treatment of PAH in Children.
Pae aediat at ri ric dru
- rugs. 2014
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- If there is unmet therapeutic need ??
- What is current standard of care??
- If CTs in PPHN should be included into
development of new drugs for PAH??
- Design of CTs in PPHN
- End points
- Duration of studies
- Duration of follow-up