2012
DOI: 10.1136/bjophthalmol-2012-302245
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Generic medications in ophthalmology

Abstract: The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therape… Show more

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Cited by 22 publications
(21 citation statements)
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“…We read the article on ‘Generic medications in ophthalmology’ by Zore et al 1 with great interest. The authors comprehensively describe the regulations that ensure ‘equivalence’ of generic products with branded versions.…”
mentioning
confidence: 99%
“…We read the article on ‘Generic medications in ophthalmology’ by Zore et al 1 with great interest. The authors comprehensively describe the regulations that ensure ‘equivalence’ of generic products with branded versions.…”
mentioning
confidence: 99%
“…For example, in a recent review, Zore et al . note the influence of the bottle tip design on the dose of topical ophthalmic preparations delivered to the eye, with drop size varying substantially between generic manufacturers of eye drops and causing different amounts of drug to be delivered to the eye .…”
Section: Defective Drug Formulationmentioning
confidence: 99%
“…However, even though generic drugs have the same active ingredients, they may differ with respect to inactive ingredients such as the adjuvant solution (Cantor 1997;Chambers 2012;Zore et al 2013). However, even though generic drugs have the same active ingredients, they may differ with respect to inactive ingredients such as the adjuvant solution (Cantor 1997;Chambers 2012;Zore et al 2013).…”
Section: Introductionmentioning
confidence: 99%
“…Without doubt, they can produce cost savings for both patients and the healthcare system. However, even though generic drugs have the same active ingredients, they may differ with respect to inactive ingredients such as the adjuvant solution (Cantor 1997;Chambers 2012;Zore et al 2013). This may affect factors such as pH, viscosity and buffer capacity and in turn pharmacokinetics, bioavailability and tolerability (Brechue & Maren 1993;Cantor 1997).…”
Section: Introductionmentioning
confidence: 99%