The typical approval requirement for a generic formulation is a bioequivalence trial showing that the generic product is essentially similar in rate and extent of absorption when compared to an already marketed product.
While such a trial is less complicated and expensive than a typical Phase III trial, there is still much to loose on inefficient execution.
Proper design and accurate concentration measurement methods are crucial to avoid repetition of the bioequivalence trial and thus reduce the risks involved for volunteers and keep the development costs down.
Another group of bioequivalence trials becoming increasingly popular are those demonstrating essential similarity of effect in cases where the plasma level of the drug is not measurable (e.g. topically applied drugs).
We have perfomed numerous trials on either type. Don't hesitate to ask for a detailed quote for your product. |
