Regulating Generic Ophthalmologic Drug Bioequivalence-Envisioning Accessibility for Patients.

Luke, Markham C; Kozak, Darby

Luke, Markham C; Kozak, Darby.

Affiliation

Luke MC; Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Kozak D; Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

J Ocul Pharmacol Ther ; 37(3): 157-161, 2021 04.

Article in En | MEDLINE | ID: mdl-33332225

Subject(s)

Eye Diseases/drug therapy; Ophthalmic Solutions/therapeutic use; Drug Approval; Humans; Therapeutic Equivalency; United States; United States Food and Drug Administration

Key words

Food and Drug Administration; bioequivalence; drug access; generic drugs; regulation

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Ophthalmic Solutions / Eye Diseases Type of study: Guideline Limits: Humans Country/Region as subject: America do norte Language: En Journal: J Ocul Pharmacol Ther Journal subject: FARMACOLOGIA / OFTALMOLOGIA / TERAPEUTICA Year: 2021 Type: Article Affiliation country: United States

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