Lakshmi Rajyam
☆    

India,
2006-11-02 08:10
(6357 d 03:43 ago)

Posting: # 358
Views: 5,792
 

 Pre-dose sample [Design Issues]

Dear Sir,

Can you clarify what is the use of taking more than one predose samples and in which conditions/drugs it will be considered.

Thanks & Regards,
Lakshmi Rajyam
Jaime_R
★★  

Barcelona,
2006-11-02 14:11
(6356 d 21:41 ago)

@ Lakshmi Rajyam
Posting: # 359
Views: 5,030
 

 Pre-dose sample

Dear Lakshmi!

❝ Can you clarify what is the use of taking more than one predose samples and in which conditions/drugs it will be considered.

  1. In single dose studies you will take predose samples in every treatment period (TP) as a demonstration of proper design (TP=1: suitability of bioanalytical method = lacking interferences, TP≥2: wash-out long enough = lacking carry-over).
  2. In multiple dose studies you will take more predose samples in every TP (at least three) in order to demonstrate steady state conditions. If total blood loss allows, all predose samples should be drawn as a compliancy control.
  3. In studies of endogenous compounds (stable baseline = no/low circadian variation) you may take more than one predose sample in every period - either shortly before administration (e.g. -1, -0.5, 0 h) or throughout the previous day in order to minimize variation (taking the mean for correction of measured concentrations).

Regards, Jaime
Dr.Pravin
☆    

Ahmedabad,
2006-11-13 07:59
(6346 d 03:53 ago)

@ Jaime_R
Posting: # 362
Views: 4,812
 

 Pre-dose sample

Dear,

In many studies in which the active metabolite of the drug are already present in the body in such cases u required more then one predose sample that again depend to consider for the baseline.

Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad
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