## Read, read, read! [Power / Sample Size]

Hi Sury,

first of all, please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! We edited 80% of your replies. Hence, this is the first warning.

» » » Can we assume the standard deviation …

» » Sure.

» » » … or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?

» » That’s also an estimate. The true value is unknown.

» » » Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?

» » Not sure what you mean here. Can you try to explain?

»

» I mean to say is in normal bio equivalence studies, we need the ISCV information in order to estimate the sample size. Does this same criteria is applicable for the standard deviation for Non-inferiority Trails too?. but i got my answer in the above explanation..

No, you got it wrong. You can assume something but

» By the above explanation, we dont need any sort of information regarding the drug nature or literature support or pilot studies for the estimation of the sample size?

Are you kidding? You will administer a drug to healthy volunteers or patients which always carries some risk. Don’t play games.

» In general BE studies, we require the pilot study or literature support for the sample size estimation (ISCV) for the pivotal studies.

»

» As we are assuming the margin of error, Standard deviation and the power (Which are required) for the non inferiority trials

»

» Correct me if i am wrong anywhere

Almost everywhere.

» it made me clear about the concept on Non-inferiority trials.

Sorry, you got me wrong. The Forum’s Policy states “We expect a

I strongly recommend to read textbooks on the topic. See this post (always get the latest editions). #1, #3, #11 are good entry points. For sample size estimation additionally:

first of all, please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! We edited 80% of your replies. Hence, this is the first warning.

» » » Can we assume the standard deviation …

» » Sure.

» » » … or we need to provide the exact Standard deviation (obtained from the literatures on the drug) ?

» » That’s also an estimate. The true value is unknown.

» » » Dose the same criteria applicable as that of the ISCV concept for the bio equivalence studies?

» » Not sure what you mean here. Can you try to explain?

»

» I mean to say is in normal bio equivalence studies, we need the ISCV information in order to estimate the sample size. Does this same criteria is applicable for the standard deviation for Non-inferiority Trails too?. but i got my answer in the above explanation..

No, you got it wrong. You can assume something but

**with a reason**!» By the above explanation, we dont need any sort of information regarding the drug nature or literature support or pilot studies for the estimation of the sample size?

Are you kidding? You will administer a drug to healthy volunteers or patients which always carries some risk. Don’t play games.

» In general BE studies, we require the pilot study or literature support for the sample size estimation (ISCV) for the pivotal studies.

»

» As we are assuming the margin of error, Standard deviation and the power (Which are required) for the non inferiority trials

»

» Correct me if i am wrong anywhere

Almost everywhere.

» it made me clear about the concept on Non-inferiority trials.

Sorry, you got me wrong. The Forum’s Policy states “We expect a

*basic knowledge*of BE/BA or related fields …” – which you are lacking. You shouldn’t rely on*anything*you find on the internet (including this forum) without a basic understanding.I strongly recommend to read textbooks on the topic. See this post (always get the latest editions). #1, #3, #11 are good entry points. For sample size estimation additionally:

- Julious SA.
*Sample Sizes for Clinical Trials.*Boca Raton; Chapman & Hall/CRC; 2010.

—

Cheers,

Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼

Science Quotes

Cheers,

Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. ☼

Science Quotes

### Complete thread:

- Non-inferiority Sample Size Estimation sury 2019-04-16 08:44 [Power / Sample Size]
- Non-inferiority Sample Size Estimation Helmut 2019-04-16 16:53
- Non-inferiority Sample Size Estimation sury 2019-04-17 06:55
- Read, read, read! Helmut 2019-04-17 10:59

- Non-inferiority Sample Size Estimation sury 2019-04-17 06:55

- Non-inferiority Sample Size Estimation Helmut 2019-04-16 16:53