Bioequivalence: Difference between revisions
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In [[medicine]] and [[pharmacology]], '''bioequivalence''', or '''therapeutic equivalency''', is "the relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease."<ref>{{MeSH}}</ref> | In [[medicine]] and [[pharmacology]], '''bioequivalence''', or '''therapeutic equivalency''', is "the relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease."<ref>{{MeSH}}</ref> | ||
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In a [[systematic review]] of drugs used for [[cardiovascular disease]], 35 of 38 [[randomized controlled trial]]s found bioequivalence.<ref name="pmid19050195">{{cite journal |author=Kesselheim AS, Misono AS, Lee JL, ''et al'' |title=Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis |journal=JAMA |volume=300 |issue=21 |pages=2514–26 |year=2008 |month=December |pmid=19050195 |doi=10.1001/jama.2008.758 |url=http://jama.ama-assn.org/cgi/pmidlookup?view=long&pmid=19050195 |issn=}}</ref> The same study also found that in spite of these results, 53% of published editorials on the topic "expressed a negative view of generic drug substitution". | In a [[systematic review]] of drugs used for [[cardiovascular disease]], 35 of 38 [[randomized controlled trial]]s found bioequivalence.<ref name="pmid19050195">{{cite journal |author=Kesselheim AS, Misono AS, Lee JL, ''et al'' |title=Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis |journal=JAMA |volume=300 |issue=21 |pages=2514–26 |year=2008 |month=December |pmid=19050195 |doi=10.1001/jama.2008.758 |url=http://jama.ama-assn.org/cgi/pmidlookup?view=long&pmid=19050195 |issn=}}</ref> The same study also found that in spite of these results, 53% of published editorials on the topic "expressed a negative view of generic drug substitution". | ||
A second study addressed the | A second study, addressed the bioequivalence of the [[anticoagulant]] [[warfarin]], which has been only available under the trade name [[Coumadin]] in North America until recently. Warfarin has a narrow therapeutic window and requires frequent blood tests of the [[International Normalized Ratio]] (INR) to make sure patients do not have a subtherapeutic or a toxic level. A study showed that replacing Coumadin with generic warfarin was safe.<ref name="pmid15914517">{{cite journal | author=Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, Crowther MA, Bates SM, Ginsberg JS. | title=Are brand-name and generic warfarin interchangeable? Multiple n-of-1 randomized, crossover trials. | journal=Ann Pharmacother | year=2005 | volume=39 | issue=7-8 | pages=1188-93 | id=PMID 15914517 | url=http://www.theannals.com/cgi/content/full/39/7/1188}}</ref> | ||
[[Generic drug]]s have been recalled for lack of bioequivalence.<ref name="urlETHEX Corporation Issues Nationwide Voluntary Recall of Products">{{cite web |url=http://www.fda.gov/oc/po/firmrecalls/ethex01_09.html |title=ETHEX Corporation Issues Nationwide Voluntary Recall of Products |author= |authorlink= |coauthors= |date=2009 |format= |work= |publisher=Food and Drug Administration |pages= |language= |archiveurl= |archivedate= |quote= |accessdate=2009-01-29}}</ref><ref name="urlETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet">{{cite web |url=http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html |title=ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet |author= |authorlink= |coauthors= |date=2008 |format= |work= |publisherFood and Drug Administration= |pages= |language= |archiveurl= |archivedate= |quote= |accessdate=2009-01-29}}</ref> | [[Generic drug]]s have been recalled for lack of bioequivalence.<ref name="urlETHEX Corporation Issues Nationwide Voluntary Recall of Products">{{cite web |url=http://www.fda.gov/oc/po/firmrecalls/ethex01_09.html |title=ETHEX Corporation Issues Nationwide Voluntary Recall of Products |author= |authorlink= |coauthors= |date=2009 |format= |work= |publisher=Food and Drug Administration |pages= |language= |archiveurl= |archivedate= |quote= |accessdate=2009-01-29}}</ref><ref name="urlETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet">{{cite web |url=http://www.fda.gov/oc/po/firmrecalls/ethex12_08.html |title=ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet |author= |authorlink= |coauthors= |date=2008 |format= |work= |publisherFood and Drug Administration= |pages= |language= |archiveurl= |archivedate= |quote= |accessdate=2009-01-29}}</ref> | ||
Revision as of 02:49, 2 February 2009
In medicine and pharmacology, bioequivalence, or therapeutic equivalency, is "the relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease."[1]
Pharmaceutical bioequivalence
In the United States, the Office of Generic Drugs of Food and Drug Administration (FDA) is dedicated to "dedicated to approving safe, effective, high-quality and bio-equivalent generic drug products for use by consumers".[2] The approval process for generic drugs began in the late 1960s. Generic drug manufacturers are required to prove that their formulation exhibits bioequivalence to the innovator product.
In a systematic review of drugs used for cardiovascular disease, 35 of 38 randomized controlled trials found bioequivalence.[3] The same study also found that in spite of these results, 53% of published editorials on the topic "expressed a negative view of generic drug substitution".
A second study, addressed the bioequivalence of the anticoagulant warfarin, which has been only available under the trade name Coumadin in North America until recently. Warfarin has a narrow therapeutic window and requires frequent blood tests of the International Normalized Ratio (INR) to make sure patients do not have a subtherapeutic or a toxic level. A study showed that replacing Coumadin with generic warfarin was safe.[4]
Generic drugs have been recalled for lack of bioequivalence.[5][6]
References
- ↑ Anonymous (2024), Bioequivalence (English). Medical Subject Headings. U.S. National Library of Medicine.
- ↑ Anonymous. Welcome to the Office of Generic Drugs. Food and Drug Administration. Retrieved on 2009-02-01.
- ↑ Kesselheim AS, Misono AS, Lee JL, et al (December 2008). "Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis". JAMA 300 (21): 2514–26. DOI:10.1001/jama.2008.758. PMID 19050195. Research Blogging.
- ↑ Pereira JA, Holbrook AM, Dolovich L, Goldsmith C, Thabane L, Douketis JD, Crowther MA, Bates SM, Ginsberg JS. (2005). "Are brand-name and generic warfarin interchangeable? Multiple n-of-1 randomized, crossover trials.". Ann Pharmacother 39 (7-8): 1188-93. PMID 15914517.
- ↑ ETHEX Corporation Issues Nationwide Voluntary Recall of Products. Food and Drug Administration (2009). Retrieved on 2009-01-29.
- ↑ ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet (2008). Retrieved on 2009-01-29.