Generic products and

WHO defines counterfeit medicine as one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products, and may include products with ... 

Bioequivalence is estabhshed between the generic product and the reference hsted product at the highest and lowest strengths and, for the reference listed product, all strengths are compositionally proportional or qualitatively the same, have the same release mechanism, and the in vitro dissolution profiles are similar. 

It is reasonable to question whether the distribution of the estimates of a drug concentration in a blood specimen might be approximated by the normal distribution. Table 1 presents the results of repeated analyses of a specimen of interference-free plasma spiked to contain a known amount of drug. These data are taken from a comparative bioavailability study in which single doses of an unmarketed generic product and the marketed brand product of a drug were administered on separate occasions to healthy males. The values presented are the first of duplicate determinations of a quality control (QC) specimen that was included with each batch of subject specimens. This was done to verify that the in-process accuracy and precision of the assay method were consistent with the values observed during the assay validation. 

One can traditionally identify three main markets for medicines patented products, generic products and those identified as self medication or over-the-counter (OTC). 

In those countries where such experimental use clauses are not in force, as is the case in much of Europe, there is normally no such rapid onset of competition when patents expire, and often the innovator product enjoys another 2 to 3 years monopoly, until generics products make it to the market. This also allows the innovator company to start marketing its own generic product, and thus benefit from the first-entry advantage in order to achieve generic market share, before competitors reach the market [19]. 

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