INVIVO INVITRO CORRELATIONSHIP - PART II

pratyesh's picture
Submitted by pratyesh on Thu, 05/29/2008 - 20:32.
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Why IVIVC is needed?

In a world of pharmacy, invitro quality control test is the only test available to assess quality of drug product. Now one has to recognize that testing of each batch for quality bioavailability on human is impractical, unethical, expensive and time consuming. So one has to use dissolution test to distinguish between acceptable and unacceptable drug product. So main objective of developing IVIVC is to establish the dissolution test as a surrogate for human bioequivalence studies performed during the initial approval process as well as with certain scale up and post approved changes.

Variables derived from in vivo & in vitro data employed for correlation are shown in table:

  INVIVO DATA IN VITRO DATA  
Peak plasma /serum concentration % Drug dissolution profile
Plasma/serum profile Disintegration time
AUC( plasma /serum)conc. profile Dissolution rate profile
Pharmacokinetic modeling
• Absorption rate constant
• Absorption half life
• Elimination half life		 Dissolution rate constant and dissolution half life 
Drug excreted in urine  Time for a certain % of drug to dissolve (e.g. t30%, t50%)
Cumulative amount of drug execrated as function of time. Parameter resulting for determination of dissolution kinetics.
% Drug absorbed –time profile First order % remaining to be dissolved-time profile
Estimated AUC Intrinsic dissolution rate
Amount of dug absorbed per ml of the volume the distribution. Logarithmic probability plot -
% Drug absorbed-time

Statistical moment analysis
Mean residence time (MRT)
Mean absorption time (MAT) 		Statistical moment analysis
Mean residence time (MRT)
Mean dissolution time (MAT)

Really worth mentioning!!!

guptashubhranshu's picture
Submitted by guptashubhranshu on Mon, 06/02/2008 - 08:55.

I think, after reading you blog pratyesh, i came to know that in these few days i have really gained a lot of facts in pharma field through blogs posted in pharmainfo. Really minor things which never came to my mind occured after i went through these blogs...Hats off to all my fellow buddies and pharmainfo...!!!

Good...

eswar's picture
Submitted by eswar on Sat, 05/31/2008 - 06:19.

Dear Pratyesh, the topic you discussed is good.
May I expect still next part covering Levels of Correlation which needs to be covered in this area?
And I like to clarify my doubt, In the above table what do you like to express about first order, just check out the plot for it. Actually it a semi-log plot.
Expecting another part from your side on IVIVC.
{eswar} G.S.N.Koteswara Rao