Preclinical Testing for an Essentially New Excipient

Materials that have had prior human use/exposure in food and cosmetics, or from the chemical industry, can be categorized as essentially new excipients. Such previous exposure is likely to be of help for oral and topical use excipient development. Excipients that have had established medicinal product use but are being used by a different dose route and/or chemically modified to enhance their properties are also likely to belong to this category. 

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