Bioequivalence and Bioavailability Forum

Dear ElMaestro!

❝ ❝ For EMA it’s [TE = (PE or PA) + BE].

❝

❝ Is it?

❝ With the old NfG for BE being replaced by the 2010 guideline, I think the definitions are no longer well defined. If we need to figure out what PE and PA means, do we really need to look it up in the guideline that has now been replaced? I tried a quickie on Eudralex and didn't find it.

Are you trying to confuse me? IMHO nothing has changed here. If you want to find the old NfG; it’s no more available anywhere in Valhalla – you may download a copy from BEBAC.
The current one more or less gives a quote of 2001/83/EC, Article 10(2)(b) in Section 1.2:

In applications for generic medicinal products according to Directive 2001/83/EC, Article 10(1), the concept of bioequivalence is fundamental. The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product. The current definition for generic medicinal products is found in Directive 2001/83/EC, Article 10(2)(b), which states that a generic medicinal product is a product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. Furthermore, the various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form.

(here we are again)

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Equivalence Trials – Proving that apples are pears
by comparing the weight. Stephen Senn (Guernsey McPearson's Drug Development Dictionary Part I, 2009)

You can’t really say “similar” if it’s the same again you want.
“Similar” means something different. Anthony Burgess (Enderby Outside, 1968)