bioequivalence

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bi·o·e·quiv·a·lent

(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.

American Heritage® Dictionary of the English Language, Fifth Edition. Copyright © 2016 by Houghton Mifflin Harcourt Publishing Company. Published by Houghton Mifflin Harcourt Publishing Company. All rights reserved.

Translations

bioequivalence

n bioequivalencia

References in periodicals archive ?

Release date- 21082019 - This is to inform the exchange that the Company's Bioequivalence Facility located at Vadodara was inspected by US Food & Drug Administration (USFDA) between 12th August, 2019 to 15th August, 2019 and between 12th August, 2019 to 20th August, 2019 for a) Bioequivalence Bioanalytical and b) Bioequivalence Clinical.

Alembic Pharmaceuticals Limited - USFDA Inspection at Bioequivalence Facility

Should licensing agencies consider user fees for post-market bioequivalence testing of critical dose and narrow therapeutic index drugs?

The globetrotting regulator

However, generics manufacturers were required to demonstrate "bioequivalence" with branded products by showing that the active ingredient in their product diffused into the human bloodstream in a manner similar to the branded product.

Generics substitution, bioequivalence standards and oversight of international pharmaceutical producers: Complex issues facing the FDA

The aim of the present study was therefore to determine the bioequivalence of RFP in FDC formulations compared with RFP in free combinations in healthy Chinese male volunteers.

Relative Bioavailability of Rifampicin in Four Chinese Fixed-dose Combinations Compared with Rifampicin in Free Combinations

"The final check of bioequivalence depends on the confidence interval.

Opening summer and making rational choices

Health Canada has set stricter bioequivalence requirements for a few drugs that are highly toxic or have a narrow therapeutic range.

Understanding generic drugs

But the Food and Drug Administration "has determined that this approach is no longer appropriate" to establish bioequivalence and "is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products."

Bupropion genetic yanked over bioequivalence

The bioequivalence problem was confirmed in an FDA-sponsored study conducted in 2010, comparing the bioequivalence of the Impax/Teva product to Wellbutrin XL 300 mg in 24 healthy adults, which determined that the generic tablets "fail to release bupropion into the blood at the same rate and to the same extent as Wellbutrin XL 300 mg," according to the statement.

Bioequivalence problem results of generic Drug

The study was designed as a randomized, controlled, 3-arm open-label, cross-over Phase I study to demonstrate the bioequivalence of Phoslyra to PhosLo Gelcaps in healthy subjects.

A randomized, controlled, three-arm, open-label, cross-over bioequivalence study comparing calcium acetate oral solution and calcium acetate gelcaps in healthy volunteers

Thus, regulatory authorities and medical prescribers would have the scientific support to expect a therapeutic equivalence if bioequivalence among the compared pharmaceutical forms is demonstrated.

Comparacion de la biodisponibilidad y la farmacocinetica entre dos formulaciones de tabletas de metformina de 850 mg en voluntarios colombianos sanos

As it is known, drugs with proven bioequivalence are reliable and inexpensive alternative drugs-brands and provide treatment required for all (Meshkovskii, 2003; Belousov, 2003; Panyushin, 2003).