Youtor
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Are generic medicines just as good as the brand? In theory, yes generic medications are just as good when it comes to clinical effect and safety. But for some medications you can see differences in how they work for you. • When a new drug comes to the market, the Food and Drug Administration (FDA) gives the drug company a exclusive rights to produce and market the drug until their patent runs out. In order to do this, the new company has to show the FDA that their version of the drug is bioequivalent to the original. • There’s a very complex definition of bioequivalence on the Code of Federal Regulations website. https://www.ecfr.gov/cgi-bin/text-idx... • Here’s a simplified version: a generic drug is bioequivalent if there is no significant difference in the way the active ingredient of the drug becomes available in your body if you take it at the same dose as the original. A significant difference is defined by bioequivalence limits which the FDA sets as 80% - 125%. These percentages refer to the range of the peak concentration of the drug and how much is absorbed over time. • Excipients are the inactive ingredients that are not held to the standard of bioequivalence. These inactive ingredients can make a difference in side effects and how the medication works for you. Some examples of excipients: • Fillers • Binders • Coating – enteric coating • Disintigrants • Sweetners • Vehicle – liquid formulation, example mineral oil • Disclaimer: All of the information on this channel is for educational purposes and not intended to be specific/personal medical advice from me to you. Watching the videos or getting answers to comments/question, does not establish a doctor-patient relationship. If you have your own doctor, perhaps these videos can help prepare you for your discussion with your doctor. • I upload every Wednesday at 9am, and sometimes have extra videos in between. Subscribe to my channel so you don't miss a video https://goo.gl/DFfT33
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