IVIVC & Biowaivers 2012 (IVIVC & BIowaivers)
|Event Date/Time: Oct 30, 2012||End Date/Time: Oct 31, 2012|
|Registration Date: Oct 05, 2012|
|Early Registration Date: Aug 07, 2012|
In Vitro-In Vivo Correlation (IVIVC) is being increasingly used to predict bio performance of dosage forms without conducting animal and/or human studies which are not only time-consuming and expensive but also might be considered ethically undesirable.
Leveraging this benefit of IVIVC to reduce the number of bioequivalence studies or in some cases to waive them off is becoming the focus area of pharmaceutical industry.
The thrust is towards getting an IVIVC - mechanics and results - that is universal (one size fits all) and that is applicable for all drugs. While there have been advances in the understanding of the intricacies of this topic, there is a lot more that needs to be learnt.
Some of the key subjects to be probed include:
â€¢Challenges in the fundamental concept of IVIVC: Can in-vitro dissolution and bioavailability be correlated and what is the basis for correlation?
â€¢Rationality behind choice and selection of the in vitro dissolution testing apparatus.
â€¢Biorelevant and discriminatory dissolution testing: Limitations and inherent failures associated with f2 and f1 analyses
â€¢Understanding the expectations of the regulators and what is the limit of regulatory specified level of correlation
â€¢Applications of IVIVC in justifying product quality attributes: Changes in process, source, physical-chemical properties, and other considerations.
â€¢Generic pharmaceuticals and IVIVC: Looking beyond the customary point-to-point Level A correlation.
â€¢Strategic mapping of IVIVC in drug development program.
â€¢Establishing clinical quality specifications through effective IVIVC: A QbD approach.