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Definitions

from The American Heritage® Dictionary of the English Language, 4th Edition

  • 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.

from Wiktionary, Creative Commons Attribution/Share-Alike License

  • adj. Describing the equivalence of multiple formulations of a drug in terms of bioavailability

Etymologies

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Examples

  • The healthcare overhaul gave the FDA the authority and a process to approve such so-called bioequivalent drugs.

    phillyBurbs.com: Home RSS feed

  • Generic or so-called bioequivalent versions of human growth hormone are in development as the original growth hormone patent approaches expiration.

    Marketwire - Breaking News Releases

  • For medicines classified as pharmaceuticals, the FDA created a system for allowing new drugs on the market if they were "bioequivalent" to a drug that had already been approved.

    James Love: Key Democrats Back BIO Industry Against Consumers to Delay Generic Medicines (Biosimilars)

  • Generics can produce blood levels as much as 20% below or 25% above that of the original drug and still be considered "bioequivalent," according to Food and Drug Administration guidelines.

    Inexact Copies: How Generics

  • Generic drug manufacturers are not insulated from lawsuits by an FDA approval process that certifies such drugs as the "bioequivalent" of their brand-name predecessors, a federal judge has ruled.

    Law.com - Newswire

  • Could you update us on what kind of bioequivalent guidelines there are for this drug?

    SeekingAlpha.com: Home Page

  • At the time, it was expected that fast-tracking the approval of "bioequivalent" drugs would bring down medical costs by $1 billion a year.

    TIME.com: Top Stories

  • These formulations are bioequivalent, meaning doses do not need to be adjusted when converting from IV to oral.

    Marketwire - Breaking News Releases

  • Because biosimilars aren't identical copies, "biotech and big pharma are looking to squash the movement by throwing bioequivalent issues and quality-control issues," says Mary Ann Crandall , an independent pharmaceutical analyst at research firm Kalorama Information.

    Generics Companies Weigh In on Biological Drugs

  • First, Generic manufacturers do not incur the cost of drug discovery and instead reverse-engineer existing brand name drugs to allow them to manufacture bioequivalent versions.

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