Bioequivalence and Bioavailability Forum

Dear Mr.Rana,

Truncated design is allowed for long half life drugs even in Parallel study for European Submission.

Even though EMEA does not directly given a statement in its BE Guideline (Guidance on the Investigation of Bioequivalence) on his stance on Truncated design in Parallel study but as per the EMEA's statement "A sampling period longer than 72 h is therefore not considered necessary for any immediate release formulation irrespective of the half life of the drug."


Also FDA states that
For either a crossover or parallel study, we recommend that sample collection time be adequate to ensure completion of gastrointestinal transit approximately 2 to 3 days) of the drug product and absorption of the drug substance. Cmax and a suitably truncated AUC can be used to characterize peak and total drug exposure, respectively.