Bioequivalence and Bioavailability Forum

Hi,

❝ ❝ I have done my exercise whatever is possible with me and produced the paper. If you find any limitation you don’t use it instead of criticizing, which is an easy job.

❝ Science does not work that way. All [sic] papers dealing with reference-scaling published so far assessed power through simulations – and for good reasons.

❝

❝ If you tell me that you have a sheep in your garden,

❝ I will believe you.

❝ If you tell me that you have a unicorn in your garden,

❝ I will go and see it myself.

❝ Do you get the analogy?

There is nothing to hide in the paper and every term was explained detail in the presented formula. Hence I don’t have to rely on your logic.

❝ ❝ I can convince my client and I don’t need your suggestion in this case and it is my headache.

❝ Studies have to be sufficiently powered (according to all BE guidelines and ICH E9). This is not the case following your “method”. I strongly suggest that you attend training in medical ethics. Human volunteers are not guinea pigs. If “convincing your client” is your primary aim, selling used cars might be a better field of work. Excuse my French.

Thanks for your suggestion with regards to the medical ethics and I don’t have to learn from you. Please be noted that power is also involved in the computation of sample size.

❝ ❝ The paper produced is purely based on the sample size estimation formula and reference is already given to you many times. For this I don’t have to refer what you have suggested. Moreover as explained earlier I did not manipulated anything in it. The same old formula was used to meet the new regulatory requirement.

❝ I really don’t understand why you are repeating this (non)argument over and over again. You have answered only a tiny fractions of my questions and concerns.

If you don’t understand that formula, please leave it.

❝ ❝ My sincere advice is that; please do not comment on anybody’s work/paper. If you did not find answer you just leave it a side and go ahead.

❝ Come on, Someswara! Don’t you know what a public forum is? Since you have chosen to publish in a predatory journal the usual path (below) is not possible.

❝ – Write a letter to the editor.

❝ – The authors will be given the chance to respond.

❝ – Both will be peer-reviewed.

❝ – In the journal’s site of the original article both will be linked and shown in literature data bases.

❝ It’s not about me. Less experienced people will find your paper and perform studies for HVD(P)s with a CV_wR of 100% in 18 subjects. This is a problem!

The formula based computation it is like that and is transparent, finally there is no manipulation. It is pure individual’s decision to go ahead. According to the formula, CV_wR increases, the BE limit will also increase. As the BE limit is in the denominator subsequently the sample size is getting decreased.

Best Regards
Someswara Rao

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Edit: Full quotes removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! The forum’s standard quote system restored. [Helmut]