Brian C Helsel, Jessica Liang, Joel E Williams, Sarah F Griffin, Hugh Spitler
Family and Friend Influences on Fruit and Vegetable Intake in Elementary Aged Children
Journal of community health
safety evaluation key aspect medical product development continual iterative process requiring thorough thinking dedicated time resources article discuss safety data transformed evidence establish refine safety profile medical product focus safety evaluation data sources statistical methods change throughout medical products life cycle challenges statistical strategies medical product safety evaluation discussed examples safety issues identified different periods premarketing postmarketing discussed illustrate different sources used safety signal identification iterative process safety assessment examples highlighted range commonly used pediatric vaccine given healthy children medical products primarily used treat medical condition adults case studies illustrate different products may require different approaches signal discovered could impact future safety assessments many challenges still remain area despite advances methodologies infrastructure public awareness international harmonization regulatory enforcement innovations safety assessment methodologies pressing order make medical product development process efficient effective assessment medical product marketing approval streamlined structured health care payers providers patients may different perspectives weighing clinical financial personal needs therapies evaluated