TERMINOLOGIES IN DRUG INDUSTRY

Abbreviated New Drug Application (ANDA)

Under an ANDA, proof of bioequivalence is enough to satisfy FDA safety
and efficacy requirements for a generic drug. The ANDA was established
by the Waxman-Hatch Act.

In addition, the generic manufacturer needs to certify that the original
drug is either (a) not patented, (b) has an expired patent, (c) has a patent
expiry date before which the generic will not be sold, or (d) has an invalid
patent or a patent that the generic does not infringe.

Accelerated Development

After the IND has been filed, a drug that can be used by patients who are
suffering from life-threatening conditions, for which no other drug
treatment exists, can qualify for accelerated development.

Biological Drugs

Biological drugs are biologics such as insulin, penicillin, blood and blood
products, vaccines, derivatives of natural substances, and extracts of
living cells are grown or cultured in separate batches.

Ethical Drugs

Also known as legal drugs.

FDA Modernization Act of 1997

It reduced FDA bureaucracy and speeding drugs and devices to patients.

Food, Drug, and Cosmetic Act of 1938

It required pharmaceutical manufacturers to submit a New Drug
Application to prove the drugs safety. The act also provided the basis for
the distinction between prescription and nonprescription drugs.

Generic Drugs

After the patent for a drug expires, other manufacturers may produce an
equivalent drug and sell it under the drug?s chemical or ?generic? name.

Good Manufacturing, Laboratory, and Clinical Practices (GMP,
GLP, and GCP)

The various Good Practices are lengthy FDA rules and regulations
governing manufacturing, laboratory, and clinical facilities.

Institutional Review Board (IRB)

IRB reviews, approves, and monitors clinical studies involving human
subjects in order to evaluating the ethical acceptability and the scientific
validity of the studies.

Investigational New Drug Application (IND)

Before testing a new drug on human subjects, the company must file an
IND. Prior to filing an IND, the sponsor develops information on the
chemistry of the drug so that it can be produced in batches of known
strength and purity. In addition, the sponsor must conduct a number of
animal studies to produce information on the pharmacology and
toxicology of the drug. For details, please, check our Section of Drug
Development.
New Chemical Entities

A chemical entity that has never been used by humans and has been
tested only on animals.


New Drug Application (NDA)

NDA is submitted to the FDA for evaluating the new drug product?s
efficacy as well as its safety.

Orphan Drug

Orphan drug refers to the drug that nobody wants to develop because its
market is small.

Over-the-Counter Drug (OTC drug)

A drug that is available to the consumer without a prescription.

Placebo

A placebo is a pharmacologically inert capsule, injection or procedure. It
has the same composition  as the test product does, except the active
ingredient (i.e. the drug).
Preclinical Research

It is the first stage in drug development involving synthesis and
purification testing in the lab and animal testing.

Prescription Drug

A drug that is available to the consumer only with a doctor?s prescription

Supplemental New Drug Application (SNDA)

The off-label uses of a drug may become additional on-label uses if the
company submits a Supplemental New Drug Application and the FDA
approves the application.

Waxman-Hatch Act

It reduced the barriers to entry for generic drug producers by allowing
them to assert safety and efficacy based on a proof that the original drug
and generic drug are bioequivalent. The submission procedure for a
generic drug is called an Abbreviated New Drug Application (ANDA).

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updated on April 26, 2005                    email zhion@zhion.com
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