bioequivalent


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bioequivalent

(bī′ō-ĭ-kwĭv′ə-lənt)
adj.
Acting on the body with the same strength and similar bioavailability as the same dosage of a sample of a given substance. Used of differing formulations of a drug or chemical compound.

bi′o·e·quiv′a·lence n.

bioequivalent

[bī′ō·ikwiv′ələnt]
Etymology: Gk, bios + L, aequus, equal, valere, to be strong
1 (in pharmacology) pertaining to a drug that has the same effect on the body as another drug, usually one nearly identical in its chemical formulation but possibly requiring a different amount to see the same effect.
2 going in and out of the body at the same rate. bioequivalence, n.

bioequivalent

Referring to a therapeutic agent that has the same pharmacologic potency and bioavailability as another drug at the same dose. Two products or formulations containing the same active ingredient are bioequivalent if their rates and extents of absorption—i.e., bioavailability—are the same.

bioequivalent

(bī″ō-ē-kwĭv′ă-lĕnt)
1. Biologically equivalent to another agent, esp.another drug or therapeutic agent.
2. A drug whose effects on the body are indistinguishable from the effects of another.
References in periodicals archive ?
Data from the 4 studies, referred to as ZOOS I-IV, respectively, reaffirm that Zensana(TM) 8 mg dose is statistically bioequivalent to the current commercially available 8 mg ondansetron (Zofran(R)) tablet, and can be conveniently administered in multiple doses.
Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused on advancing cancer care, announced the positive results of pivotal clinical trial ZOOS 1 (Zensana(TM) Ondansetron Oral Spray), a study which definitively demonstrated Zensana(TM) (ondansetron oral spray) 8 mg dose is bioequivalent to the current commercially available 8 mg tablet (Zofran(R); GlaxoSmithKline).
Results demonstrated the tacrolimus and Prograf capsules are bioequivalent under fed and fasting conditions.
Under data exclusivity, a controversial rule first imposed in 1987, for a period of about eight years after approval of a new drug, a country cannot accept an application for a generic bioequivalent to a brand-name drug even if the patent is expired or is otherwise not a problem, because that is called "unfair" use of the knowledge that the brand-name drug worked in the first place.
over PR Newswire, we are advised by a representative of the company that the first paragraph, second sentence should read "Endo's oxycodone extended-release tablets are AB-rated bioequivalent versions of the 10mg, 20mg and 40mg strengths of OxyContin(R), a product of The Purdue Frederick Company that is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time" rather than ".
812) would let the Food and Drug Administration approve generic drugs that are not bioequivalent to their brand-named counterparts.
Fluocinonide E Cream is bioequivalent to Medicis' Lidex(R), and the market for this product is estimated by industry sources to be approximately $5,000,000.
has announced that the United States Food and Drug Administration has accepted its Abbreviated New Drug Application (ANDA) submission for a bioequivalent version of Depakote(R).
The FDA has determined that these formulations, which will be manufactured at Bentley's facilities in Spain, are bioequivalent and have the same therapeutic effect as that of the reference drug, Zocor([R]) (Merck & Co.
It is a bioequivalent of Roche's Klonopin, with an estimated total US drug market of $140 million.
Diflorasone Diacetate Cream is bioequivalent to Dermik Laboratories' Psorcon(R) Cream.
The breadth of his business experience will allow him to make a major contribution to the development and marketing of bioequivalent products utilizing the ACCU-BREAK[TM] technologies, as well as allowing him to play an important role in our technology out-licensing efforts.