Bhupesh
☆    

India,
2008-07-09 11:10
(6564 d 18:40 ago)

Posting: # 2009
Views: 6,127
 

 Sampling time point selection [Design Issues]

Hi All :-)
Regards
I am looking for some articles or guidelines that can give me idea about how to select sampling time points during BA/BE studies and what critical points one should consider while determining the sampling time points?
Please help me out.
Thanks a lot.
d_labes
★★★

Berlin, Germany,
2008-07-09 12:34
(6564 d 17:15 ago)

@ Bhupesh
Posting: # 2010
Views: 4,824
 

 Sampling time point selection

Dear Bhupesh,

the Search field in the right above corner of the forum is your friend :-P

Regards,

Detlew
martin
★★  

Austria,
2008-07-09 12:57
(6564 d 16:53 ago)

@ Bhupesh
Posting: # 2011
Views: 4,971
 

 Sampling time point selection

dear bhupesh !

selection of sampling time points following a single dose is addressed for example on pages 133 to 134 in

Cawello W. (2003). Parameters for Compartment-free Pharmacokinetics. Standardization of Study Design, Data Analyes and Reporting. Shaker Verlag, Aachen.

[...] the blood sampling period should be continued for at least three-times preferably five-times the terminal half-life following tmax. [...] the time points for blood sampling are usually fixed as follows: the first five time points are selected before tmax (inclusive), the second five time points between tmax and t1/2 (inclusive) and the last five time points between t1/2 and five-times t1/2 (inclusive) [...]

Note:
  • you have to ensure that the bioanalytical methodology is able to measure concentrations above the limit of detection at time 5*t1/2.
  • in the case of an injection bolus, tmax is usually the first time point after study administration and you have to adopt this suggestions accordingly.
  • there are guidelines for specific drugs explicitly stating sampling time points!
hope this helps

martin
Helmut
★★★
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Vienna, Austria,
2008-07-09 15:30
(6564 d 14:19 ago)

@ martin
Posting: # 2012
Views: 4,818
 

 Guidelines: sampling time points for API

Dear Martin!

❝ - there are guidelines for specific drugs explicitly stating sampling time

❝ points !


I did not know that! Can you please give an example?

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martin
★★  

Austria,
2008-07-09 15:46
(6564 d 14:03 ago)

@ Helmut
Posting: # 2013
Views: 4,826
 

 Guidelines: sampling time points for API

dear hs!

some examples:
human plasma derived factor VIII and IX
human plasma derived von Willebrand factor

best regards

martin


Edit: Documents linked. [Helmut]
Helmut
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Homepage
Vienna, Austria,
2008-07-09 15:58
(6564 d 13:52 ago)

@ martin
Posting: # 2014
Views: 4,861
 

 Thanks!

Dear Martin!

Thanks for the NfGs – quite exotic ones for me, dealing mainly with ‘small molecules’;-)

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