Glossary

Nerve cells, the structural and functional unit of the nervous system. A neuron consists of a cell body and its processes, a neuraxon, and one or more dendrites. Neurons function by the initiation and conduction of impulses and transmit impulses to other neurons or cells by releasing neurotransmitters at synapses.

(ICH Q3C (R4)) The ability of a substance to cause adverse effects on the nervous system.

In the early stages of research, a new substance is called a new chemical entity, a chemical entity that has never been used by humans and has been tested only on animals.

Under the Food, Drug, and Cosmetic Act of 1938, the NDA was submitted to the FDA enumerating the uses of the drug and providing evidence of its safety. If the FDA found no reason to object, the NDA was automatically approved within sixty days. But since 1962 the FDA evaluates proof of efficacy as well as proof of safety, and the company must wait for FDA approval no matter how long that takes. On average, the NDA review process lasts for two years (as of the mid-1990s, some evidence suggests times have shortened). The NDA review is handled by the FDA's Center for Drug Evaluation and Research (CDER). Once the CDER deems the NDA fileable, the medical, biopharmaceutical, pharmacology, statistical, chemistry, and microbiology departments of the CDER review it. The length of an NDA application can reach one hundred thousand pages of material. If the departments pass the NDA, an advisory committee meets. If the advisory committee is satisfied with all of the findings, a labeling review takes place. Once the labeling review is complete, the NDA is approved, and the drug is ready to be marketed.

After the animal testing stage, FDA decides whether it is reasonably safe for the company to move forward with clinical trials – studies that evaluate the safety and effectiveness of a drug in healthy people and in patients. The drug company submits the results of such studies to FDA for review. The agency conducts a thorough review of the safety and effectiveness data, and considers how the benefits compare to the risks when making a decision of whether or not to approve a drug.

(ICH Q6A) 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.

(ICH Q6A) 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.

(ICH Q3A (R2)/Q3B (R2)) The designated therapeutic moiety that has not been previously registered in a region or member state (also referred to as a new molecular entity or new chemical entity). It can be a complex, simple ester, or salt of a previously approved drug substance.

(ICH Q1A (R2)) 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.

National Formulary

New Formulation and Delivery Alternative

Normal Flow Filtration

Next Flight Out

Normal Flow Parvovirus

National Fire Protection Association (United States)

NFPA has developed a scale for rating the severity of fire, reactivity, and health hazards of substances. References to these ratings frequently appear on MSDSs.

Nerve Growth Factor

Nerve Growth Factor Receptor

Non-Hodgkin's Lymphoma

National Hardwood Lumber Association

Normal Human Serum Albumin

A blood plasma fraction usually prepared by Cohn cold ethanol precipitation. Dispensed as a 5% to 25% protein solution.

National Homeland Security Research Center (EPA)

National Institute on Alcohol Abuse and Alcoholism

An institute in NIH.