generic drug vs brand name drug: definitions
comparisons between generic and brand name drugs must first understand what each is and what characterizes them.
Sunday, March 20, 2011
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A brand name drug is synthesized by one laboratory, which originally commissioned the investigation of the drug, studies of effectiveness, efficiency, bioavailability (1), etc. Is associated with a patent that prevents any other pharmaceutical company can synthesize and commercialize the drug for about 20 years, including the time that drug studies and marketing. And is written on the packaging and brand name of the drug.
A generic , as described in Royal Decree 1345/2007, Article 2.35 is " the drug has the same qualitative and quantitative composition in active substances and the same pharmaceutical form, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies . " This, said in fine Christian, means that the generic drug must have the same composition quality and quantity of active ingredient must be the same (tablet, syrup, capsule) and should have been shown to exert the same effect, at the same time and in the same way the brand name drug. Besides all this, it must have been 10 years since it began to be marketed reference product (the brand), proving that it is widely useful, it has serious side effects that motivate withdrawal or any other contraindication to its synthesis and marketing as a generic. And bears no brand name on the package, only the name of the drug.
Here we are today. Tomorrow, more and better:) In addition recommend this post Soitu Esther Samper, which summarizes some of what I'm going to tell these days.
Here we are today. Tomorrow, more and better:) In addition recommend this post Soitu Esther Samper, which summarizes some of what I'm going to tell these days.
1. Bioavailability is the amount of drug that reaches its target within a certain time. For example, actual amount of paracetamol tablet whole blood is, covering the whole body, at a time X, to exert its analgesic and antipyretic (reduce fever).
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