Bioequivalence and Bioavailability Forum

Hello everybody.

Has been a while since I make a comment on the forum and since this topic is also of my interest, I’d like to use your statements and to express my opinion on the matter.

❝ You will not loose the war by using a “wrong” term

Indeed, no one will lose the war by using a wrong term. However, depending on the level of maturity of the sponsor of the study, he can make a bad judgement about your knowledge regarding clinical trials. The fact is that many companies still insists on putting a BE study in one of the 4 phases of the clinical trials that are, IMHO, just fitted for a new drug (and not a new formulation of a known drug). I really don’t see the point in that!!!!

❝ Phase III is done in patients (endpoints efficacy & safety), whereas BE mainly employs healthy subjects

I’m not sure if the study’s classification based on its population (either patients or healthy volunteers) would be the best way to recognize the phase, after all a clinical trial of bioequivalence can be conducted also with patients. The truth is that when these 4 phases were envisioned there were no generic copies (these would come later). Through is all, I believe that if it was really necessary to choose one of the four phases it would be more safe to classify the study based on its objectives, in what is going to be investigated and among the general objectives of each phase. In this sense I’ve made, based on my bibliographic surveys, a summary description of the objectives of each one of the phases of development of a new drug (again, not for a generic drug) so that we could try to identify the one that most fits to BE:

Phase I: Pharmacology description of the new drug (e.g. assessment of absolute bioavailability, dose proportionality, drug to drug interaction, etc.) and assessment of toxicity of the drug (dose scalling studies).

Phase II: Preliminar description of the efficacy (isolated) and deepening of the knowledge aquired in phase I regarding toxicity.

Phase III: Comparison between the new drug and the standard treatment already established (equivalence, non inferiority and superiority studies)

Phase IV: Follow-up on adverse event and post-registry changes.

IMHO when it comes to BE studies, regardless of the fact that we are not assessing directly the safety and efficacy of the new drug with a standard treatment in patients, we are comparing the safety and efficacy of a new generic copy indirectly, with a certain standard elected by the regulators. In this sense, I really can’t understand the reason why one would classify BE as a phase I study. In general, what we’re investigating in a phase I study is the description of a new drug and not the comparison with another drug/formulation (please correct me if I’m wrong). That usually happens in Phase III. So I agree with Lucas’ position that if it was necessary to classify it, I would say that BE studies are something like a Phase III special.

Thank u all…