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 ?
It is expected that two bioequivalent drug formulations have comparable in vivo performances and, therefore, share a common optimized dose regimen and an identical clinical efficacy and safety profile (5,6).
It is engaged in bioequivalent ACCU-BREAK product development through a joint venture with Strides Arcolab Ltd.
Products launched in 2006 include Simvastatin tablets, AB-rated and bioequivalent to Merck's Zocor; Pravastatin Sodium tablets, AB-rated and bioequivalent to Bristol-Myers Squibb's Pravachol; Sertraline Hydrochloride tablets, AB-rated and bioequivalent to Pfizer's Zoloft tablets; Ondanstron injection, AB-rated and bioequivalent to GSK's Zofran; Budeprion XL (Bupropion HC1 ER tablets), AB-rated and bioequivalent to Boehringer Ingelheim's Mobic.
The Citizen Petition also addresses the requirement that the labeling for a bioequivalent product be substantially identical to that of the approved branded product.
Recently launched products include simvastatin tablets USP, AB rated and bioequivalent to Merck's Zocor; sertraline HCl Tablets, AB rated and bioequivalent to Pfizer's Zoloft; pravastatin sodium tablets, AB rated and bioequivalent to Bristol-Myers Squibb's Pravachol; deferoxamine mesylate for injection, USP, AP rated to Novartis' Desferal; desmopressin acetate tablets, AB rated and bioequivalent to Aventis' DDAVP tablets; and zonisamide capsules, AB rated and bioequivalent to Dainippon's Zonegran.
The traditional proliferation of non-bioequivalent, branded generic or copycat products is slowly being replaced by the steady introduction of bioequivalent generics in Latin America.
Since the beginning of 2003 Teva USA has introduced 24 new products to the market, among them Tamoxifen Citrate tablets, AB rated and bioequivalent to AstraZeneca PLC's Nolvadex; Budprion SR and Buproban (Bupropion HCI extended-release tablets), AB rated and bioequivalent to GlaxoSmithKline PLC's Wellbutrin SR and Zyban, respectively; and Oxycodone HCI extended-release tablets, AB rated and bioequivalent to Purdue Pharma LP's OxyContin.
When a branded product loses patent protection, bioequivalent generic versions of the original compound can be launched by competitors, invariably at a lower price; this leads to strong competition for the branded product, which then experiences declining sales and market share.
Since the beginning of 2002 Teva has introduced 15 products to the market, including AB-rated versions of amoxicillin and clavulanate potassium tablets, the bioequivalent of GlaxoSmithKline's anti-infective drug Augmentin; nizatidine capsules, bioequivalent to Eli Lilly and Co.
This is a win-win relationship and provides us with the first candidate, targeting colon cancer, to enter our SuperAntibody Bioequivalent Program.