Pankaj Bhangale
☆    

India,
2011-09-05 11:30
(5054 d 06:24 ago)

Posting: # 7334
Views: 6,442
 

 Lag Time Manual Calculation [PK / PD]

Dear All,

Please anyone can guide me, how to calculate lag time from subject concentration data vs time? I want manual calculation of lag time.

Following is example to calculate lag time.
Time  Concentration
(Hrs)   (ng/mL)
 0.00    0.00
 1.00    1.79
 2.00    3.48
 3.00    4.42
 3.50    4.44
 4.00    4.72
 4.33    5.12
 4.67    5.45
 5.00    4.92
 5.33    4.45
 6.00    4.12
 8.00    3.03
10.00    2.07
12.00    1.65
24.00    0.64
36.00    0.20
48.00    0.00
72.00    0.00

What is significance & interpretation of lag time in BE study? and Is there any correlation occurred between tmax & lag time?

Please Help me


Best Regards,
PANKAJ BHANGALE
Helmut
★★★
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Vienna, Austria,
2011-09-05 15:15
(5054 d 02:39 ago)

@ Pankaj Bhangale
Posting: # 7335
Views: 5,503
 

 Lag Time Manual Calculation

Dear Pankay,

❝ Please anyone can guide me, how to calculate lag time from subject concentration data vs time? I want manual calculation of lag time.

  1. Come up with a suitable definition of tlag (sounds trivial, but isn’t; see below).
  2. Select an algorithm.
  3. Perform the calculation. :cool:
For some background [image] search the forum; read the posts and references given in them.

❝ What is significance & interpretation of lag time in BE study?


Tlag plays some role in enteric coated (gastric resistant) formulations (examples: PPIs, diclofenac). With these types of formulations you may expect a lot of variability – not caused by the formulation itself, but due to gastric emptying.

❝ Is there any correlation occurred between tmax & lag time?


Partly. If the coating ‘works’ similar in both formulations and ka is also similar you should get a good correlation. If one of these are different you would need PK modeling which is not acceptable in BE studies… :-D

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Pankaj Bhangale
☆    

India,
2011-09-06 11:49
(5053 d 06:05 ago)

@ Helmut
Posting: # 7336
Views: 5,306
 

 Lag Time Manual Calculation

Dear Helmut,

Very thank you for the quick reply with information.


Best Regards,
Pankaj Bhangale
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