Original and Generic Drugs

Aim Show that two pharmaceutical products have the same pharmacokinetic properties and the same bioavailability. 

Study design Randomised two period cross-over, 12-36 healthy volunteers. 

Comparisons Area under the curve (AUC), Maximum concentration (Cmax) and time to Cmax (Tmax) 

Comment. The studies summarise intra- and inter- individual variability. 

The company that applies for approval of the generic product must present full chemical and pharmaceutical documentation. If the new product does not fall within the definition of a generic medicinal product compared to the reference product the results of the appropriate pre-clinical tests or clinical trials should be provided (EU 2001 specific Article 10 (3)). It should be noted that the pharmaceutical and chemical quality is strictly regulated and includes all medications. 

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