National Association of Chemical Distributors (NEW)
Non-Animal Methodologies or New Approach Methodologies
Nanotechnology is an emerging technology that can be used in a broad array of regulated products. The nanoscale range differs by region.Nanoscale materials can exhibit different chemical or physical properties, or biological effects compared to larger-scale counterparts. [
Validated and reliable in silico, in chemico, in vitro, and ex vivo approaches, or combination for replacement, reduction, or refinement of animal use (e.g., 3Rs) for providing information on chemical hazard and risk assessment that can be applied to regulatory decision making.
A functional group classified as a probable human carcinogen. It is therefore a contamination concern for pharmaceuticals, for which a risk assessment is often performed on the API or excipient.
National Medical Products Administration (China)
No-Observed-Adverse-Effect Level
No-Observed-Effect Level
The main component for which the excipient is named.For an excipient mixture, the main component may not be present at greater than 50% .
The variability expected to be obtained for the excipient during typical processing and evaluation when the process operates in a state of control with no special causes of variation.
An excipient used for the first time in a drug product or a new route of administration or a higher level of use in a drug product. When a novel excipient chemistry is used for the first time in a drug product, it is referred to as a new chemical entity (NCE).
National Sanitation Foundation
Nutrition labelling is a description intended to inform the consumer of nutritional properties of a food. Nutrition labelling consists of two components: (a) nutrient declaration; (b) supplementary nutrition information.amin A, vitamin C, calcium, iron. [41]
