Bioequivalence and Bioavailability Forum

Hi Someswara,

❝ ❝ Your article is a slap in the face of the ones devoting a lot of time and efforts into developing fast algorithm and setting up simulations.

❝ I never questioned anyone’s paper or work what they have done, instead I have learned much out of it. 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?

❝ ❝ In many cases studies designed according to your tables will be (extremely) underpowered (i.e., producer’s risk larger than desired). […] However, sometimes you’ll make a lucky strike (producer’s risk substantially smaller than targeted). Study overpowered, more subjects than required treated.

❝ 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.

❝ ❝ ❝ We have compared the obtained sample size by using our method with Tóthfálusi & Endrényi (2012) method […]

❝ ❝ Did you bother to look at the table and plots in my previous post? If you don’t see differences likely you are .

❝ 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.

❝ ❝ ❝ I am not bothered about the ranking of journals …

❝ ❝ […] why didn’t you submit the manuscript to a reputable journal […]? Or were you in private afraid that it will fail to survive any serious peer-review?

❝ 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!