N
NACD

National Association of Chemical Distributors

Neat Excipient

The pure excipient, containing no other materials. [7]

Neurotoxicity

The ability of a substance to cause adverse effects on the nervous system. [16]

New Drug Product

A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients.

New Drug Substance

The designated therapeutic moiety, which has not previously been registered in a region or Member State (also referred to as a new molecular entity or new chemical entity). It may be a complex, simple ester, or salt of a previously approved drug substance. [12, 15]

New Excipient

An excipient used for the first time in a drug product or a new route of administration. [7] Equivalent to "Novel Excipient".

New Molecular Entity

An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or non-covalent-bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance. [13]

No-Observed-Adverse-Effect Level (NOAEL)

The highest dose of a substance that, in a given toxicity test, causes no biologically significant effects in the exposed test animals. [7]

No-Observed-Effect Level (NOEL)

The highest dose of substance at which there are no biologically significant increases in frequency or severity of any effects in the exposed humans or animals. [16]

NOAEL

No-Observed-Adverse-Effect Level

NOEL

No-Observed-Effect Level

Nominal Component

refers to the component by which a particular excipient is named.

Non-conforming Material

Material that does not meet the manufacturer?s specifications or has not been manufactured according to applicable GMPs. [3]

Non-Official Method (Non-Official Source)

An analytical technique not found in compendia or other listings of official analytical methods. [7]

Nonconformance

A non-fulfillment of a requirement defined within a quality management system.

Normal Variability

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.

Nutritional Information

The declaration of specific nutritional components such as total calories, calories from fat , total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, iron. [6]