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Sai
Junior

2018-02-22 03:11

Posting: # 18441
Views: 1,182
 

 Sampling Time points and Sample Size [Regulatives / Guidelines]

Hello Everyone,

I'm new to this group as well as to BA/BE job.

Can someone help in calculating the sampling points as well to calculate the sample for a study with an example.

Also please guide me with some documents of proof or books.

Thanks a lot in advance.
jag009
Hero

NJ,
2018-02-23 18:06

@ Sai
Posting: # 18451
Views: 929
 

 Sampling Time points and Sample Size

Why do you need to calculate sampling time points? You need to draft your sampling time points based on half-life of the drug and the drug in-vivo release profile. If it's a generic product then you draft your time points based on the brand's profile. If it's a NDA then you draft your time points based on your expected drug release profile.

J
Sai
Junior

2018-02-23 19:40

@ jag009
Posting: # 18452
Views: 914
 

 Sampling Time points and Sample Size

Thanks Jag for the response. I'm writing a protocol to a generic drug. I would like to know how to use half-life or Tmax and figure out or calculate the sampling time points.

Regards
Sai
Maitri
Junior

India,
2018-03-04 10:59

@ Sai
Posting: # 18495
Views: 741
 

 Sampling Time points and Sample Size

» Thanks Jag for the response. I'm writing a protocol to a generic drug. I would like to know how to use half-life or Tmax and figure out or calculate the sampling time points.
»
» Regards
» Sai

Hi Sai,

This sampling should continue for at least three or more terminal elimination half-lives of the drug to capture 90 percent of the relevant AUC. There are some other key parameters to be considered to calculate sampling time points. Blood samples be drawn at appropriate times to describe the absorption, distribution, and elimination phases of the drug. For most drugs FDA recommend that 12 to 18 samples, including a pre-dose sample, be collected per subject per dose. The exact timing for sample collection depends on the nature of the drug and the rate of input from the administered dosage form. The sample collection should be spaced in such a way that the maximum concentration (Cmax) of the drug in the blood and terminal elimination rate constant can be estimated accurately.

Regards,
Maitri
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