Generics Substitution, Bioequivalence Standards, and International Oversight: Complex Issues Facing the FDA
| Autor: | Preston Mason, Roger Bate, Harry M. Lever, Dinesh Thakur, Tod Cooperman, Joe Graedon, Erin R. Fox, Aparna Mathur |
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| Rok vydání: | 2015 |
| Předmět: |
Process (engineering)
Transparency (market) media_common.quotation_subject Accounting Bioequivalence Pharmacology Toxicology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Generic drug Production (economics) Medicine Drugs Generic Humans Quality (business) 030212 general & internal medicine media_common Drug Labeling business.industry United States Food and Drug Administration Substitution (logic) United States Product (business) Therapeutic Equivalency Drug and Narcotic Control business |
| Zdroj: | Trends in pharmacological sciences. 37(3) |
| ISSN: | 1873-3735 |
| Popis: | The regulations for assessing the quality of generic drugs and their bioequivalence to innovator products are outdated and need to be substantially modernized. There are multiple reasons why these changes are needed, including: (i) the regulations remain largely unchanged since the passage of the Hatch–Waxman Act in 1984; (ii) medication therapies have become substantially more complex over the three decades since the passage of the Act; (iii) a switch from an innovator drug to a generic drug, or switching from one generic to another, is not a benign process – there is substantial clinical professional judgment involved and in some instances these decisions should be better informed; and (iv) pharmaceutical ingredients for finished products, whether innovator or generic, are from multiple sources of supply, adding variability in their production, and which may not be accounted for in specification tolerances. When these elements are viewed together, they clearly suggest that more transparency of responsible manufacturers in product labels and updated standards for bioequivalence are required. |
| Databáze: | OpenAIRE |
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