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drp
Junior

India,
2018-08-10 07:09

Posting: # 19162
Views: 331
 

 Sampling time [Design Issues]

Dear All,
My query is how is Sampling time points and number of sampling decided in bioequivalence study.

Thanks and regards:
drp


Edit: Category changed; see also this post #1[Helmut]
Helmut
Hero
avatar
Homepage
Vienna, Austria,
2018-08-10 11:51

@ drp
Posting: # 19165
Views: 289
 

 Sampling time

Hi drp,

you need to know the PK of the drug (distribution, elimination) and the properties of the formulation (absorption, lag-time). For some general approaches see here and there.

Cheers,
Helmut Schütz
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Durga
Junior

India,
2018-08-14 07:37

@ drp
Posting: # 19167
Views: 153
 

 Sampling time

We need to check the molecule available PK profile of drug (absorption, distribution and elimination). we need to read the guidelines how many sampling time points need to be set at different phases as per above mentioned.

you need to check the metabolite pharmacological activity (if applicable)

bases on the formulation also. it is also very important.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5. Please follow the Forum’s Policy[Helmut]
jag009
Hero

NJ,
2018-08-18 00:17

@ Durga
Posting: # 19171
Views: 69
 

 Sampling time

» We need to check the molecule available PK profile of drug (absorption, distribution and elimination). we need to read the guidelines how many sampling time points need to be set at different phases as per above mentioned.

"Read the guidelines how many sampling time points needed"? What guidelines?

John
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