Cmax
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India,
2010-08-13 20:12
(5384 d 07:45 ago)

Posting: # 5782
Views: 7,311
 

 Non Linearity [PK / PD]

Hai Everyone,
Is it possible to find out whether the drug follows linear or non linear kinetic from a single dose study ?
thanks and regards
Cmax
ElMaestro
★★★

Denmark,
2010-08-13 20:31
(5384 d 07:26 ago)

@ Cmax
Posting: # 5784
Views: 6,010
 

 Non Linearity

Hi Cmax,

if by "single dose study" you mean a single study in which one dose level has been applied then the answer is no. To investigate linearity several dose levels need to be investigated.

Pass or fail!
ElMaestro
Helmut
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Vienna, Austria,
2010-08-13 21:11
(5384 d 06:46 ago)

@ ElMaestro
Posting: # 5785
Views: 6,071
 

 Non Linearity (SD vs. MD)

Dear ElMestro & Cmax (interesting nick)!

❝ To investigate linearity several dose levels need to be investigated.


... and the design depends on how much previous information about the drug one has. Single dose studies generally suffice for most drugs, but for new drugs (i.e., full characterisation of pharmacokinetics) one has to opt for steady state. Otherwise time-dependent effects (e.g., enzyme-induction or -inhibition) may not be detected.

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Cmax
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India,
2010-08-27 22:04
(5370 d 05:53 ago)

@ Helmut
Posting: # 5861
Views: 5,877
 

 Non Linearity (SD vs. MD)

dear all,
thanks and i rephrase my question here "if i have a BE study from that how we can make it out is it follows non linear kinetic... if you search in internet few works shows it follows non linear PK..." ;-)
Helmut
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Vienna, Austria,
2010-08-28 16:29
(5369 d 11:28 ago)

@ Cmax
Posting: # 5863
Views: 5,850
 

 BE # dose proportionality

Dear Cmax!

❝ if i have a BE study from that how we can make it out is it follows non linear kinetic...


BE studies (test vs. reference at the same dose level) are not suitable to assess dose proportionality. I have occasionally seen 4-way cross-over studies (three dose levels of test vs. one dose level of reference).

❝ if you search in internet few works shows it follows non linear PK...


So what?

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