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Perform IVIVC for Delayed Release Drug Formulations


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#1 Simon Davis

Simon Davis

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Posted 24 September 2019 - 04:35 AM

Professor Cardot will be giving this webinar tomorrow;

Topic: How to Perform IVIVC for Delayed Release Drug Formulations
Date: September 25, 2019
Time: 11:00 am EDT

https://lp.certara.c...gistration.html

 

https://go.certara.c...0000XN73034QzV0

 

Do you use IVIVC— a mathematical tool that describes the relationship between a drug’s in vitro properties and in vivo PK— to waive the requirement to show evidence of in vivo bioavailability or bioequivalence? Then you know how this approach can help guide formulation and process development changes, support and validate the use of in vitro dissolution methods, and set clinically relevant dissolution specifications to ensure product quality.

In theory, developing an IVIVC for immediate release oral formulations is straightforward.

But what about delayed release drug formulations?

In this case, IVIVC can pose a real challenge. For this type of formulation, you can’t average subjects’ plasma time-concentration profiles nor can you predict Cmax or Tmax from in vitro dissolution assays.

This webinar will show you how to use a time correction factor to help establish a meaningful IVIVC for delayed release formulation drugs.


Edited by Simon Davis, 24 September 2019 - 04:40 AM.


#2 Simon Davis

Simon Davis

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Posted 24 September 2019 - 08:53 AM

Also don't forget there is an intrroduction to IVIVC, (102-CL) IVIVC Toolkit for Phoenix WinNonlin course in Montpellier 14-15 Nov.  It is a 1.5 day course kindly hosted by MedinCell S.A  but anyone may attend.   

I hope you can join us - please see the sign-up page below.  https://www.certarau...er&course_id=28

 

  Simon.






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