Bioequivalence and Bioavailability Forum

Maulik,

TE, PE or BE are the type of equivalence studies. Which one is required would depends on the regulator and also the indication for the drug. FDA has a guidance for specific formulation in the following link.

TE is always conducted with patients. BE (in Vivio) is usually conducted with healthy subjects. PD (Pharmacodynamics) can be done on healty subjects of patients but usually done on patients. PE (in vitro) is always conducted in the lab. Most of the time the studies should be done in the following order to show Therapeutics Equivalence: PE ---> BE ---> PD or TE. For most of the generic drugs, PD or TE is not required. It does not mean TE=PE+BE. It just means PE and BE is sufficient to show equivalence of two drugs and TE is not required. A drug passes PE has a good chance to pass BE and a drug passes PE and BE has a good chance to pass PD or TE, but not always.

These are my understanding from my experience of working in the generic field for 9 years and dealing with EMEA and FDA regulations. Hope it helps.

Yan

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Edit: FDA document linked. Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]