topic Re: How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry in Discussions

How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry

ParsaKarthik — Fri, 07 Jun 2019 15:42:54 GMT

Hi, is it possible to calculate the power of a bio study design using JMP?

Re: How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry

Chris_Kirchberg — Fri, 07 Jun 2019 16:35:56 GMT

Could you tell us more about the design and what you are trying to test? There are different ways to calculate power, but it depends on where are you starting from and what you are trying to accomplish.

Thanks,

Re: How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry

ParsaKarthik — Sat, 08 Jun 2019 06:53:04 GMT

Hi @Chris_Kirchberg

In the bio study, follwing are the steps that happen in sequence

1. selection of no. of volunteers

2. we give both the Innovator(Reference formulation) & the Test(generic) formulation to the volunteers

3. we then collect the blood, measure the concentration of the drug in the volunteers

4. This is followed by the geometric mean calculation of the Test and Reference

5. Finally, the Test/Reference ratio for the geomteric mean of the Test and reference is calculated.Regultory acceptance criertia is that the Test/Reference ratio along with the Confidence intervals should be in the range of 80-125 to conclude that there is no significant difference between the Reference and Test formulation

Selection of no. of volunteers is based on the power calculation, but i am not sure about the process/criteria that are involved. Kindly update me if this is possible with JMP.

Re: How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry

Chris_Kirchberg — Mon, 10 Jun 2019 12:44:35 GMT

Hi @ParsaKarthik,

That discription helps. Basically you are looking for the power to detect a difference in two groups with a certain level of confidence.

There is a Power and Size calculator for testing two means or proportions in the DOE menu under Design Diagnostics in JMP 13 and 14. I know it is not the geometric mean, but I think these are the types of calculators you are looking for.

There are also some calculators of different types in our Sample Data section under the help Menu.

Maybe someone has a script to do this for geometric mean.

Best,

Re: How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry

ParsaKarthik — Wed, 12 Jun 2019 12:18:06 GMT

@Chris_Kirchberg
Kindly help me on this, assuming the requirement as arithmetic mean. I want to understand the process, i am not so concerned if it is an arithmetic mean or a geometric mean.
Thanks!

Re: How to calculate the Power of a Pharmacokinetic study in Pharmaceutical industry

Chris_Kirchberg — Wed, 12 Jun 2019 16:41:35 GMT

HI @ParsaKarthik,

Take a look at this help page that explains how to use the Sample Size and Power Calculator.

https://www.jmp.com/support/help/14/prospective-sample-size-and-power.shtml

Hope this helps.

Best,