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- W1804695778 abstract "Raw materials in pediatric formulations such as excipients, food ingredients, and active pharmaceutical ingredients (APIs) have received significant attention from regulatory agencies worldwide in recent times due to safety concerns. Not all excipients and food ingredients are “inert” and have been shown to interfere with the growth and development process in pediatric population. Though raw materials incorporated in drug products require extensive safety testing prior to their inclusion in the formulations, there are very few excipients that have undergone randomized clinical trial (RCT) in the pediatric subpopulation. Therefore, this chapter will provide an overview of selected excipients and APIs that are routinely included in pediatric products with reference to their chemical structure, chemical reactivity, and allowable daily intake for pediatric use." @default.
- W1804695778 created "2016-06-24" @default.
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- W1804695778 date "2014-01-01" @default.
- W1804695778 modified "2023-09-27" @default.
- W1804695778 title "Excipients and Active Pharmaceutical Ingredients" @default.
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- W1804695778 doi "https://doi.org/10.1007/978-1-4899-8011-3_24" @default.
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