Bioequivalence and Bioavailability Forum

Dear Helmut,

❝ whereas in the EU one may get also regulatory approval for pharmaceutical alternatives (e.g., IR capsule vs. reference IR tablet).

❝ For details have a look at the Guideline-Collection: US-FDA, EU-EMA.

Could you please refer me to the part of the guidelines that says that you can use a pharmaceutical alternative reference (if the pharmaceutical equivalent is unavailable).

The only lines I could find were on page 7/27, "In an application for extension of a medicinal product which has been initially approved under Art.8(3) of Directive 2001/83/EC and when there are several dosage forms of this medicinal product on the market, it is recommended that the dosage form used for the initial approval of the concerned medicinal product (and which was used in clinical efficacy and safety studies) is used as reference product, if available on the market."

Thanks