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# New Approach to IVIVC Needed in NDAs: FDAers
- URL: https://www.fdaweb.com/new-approach-to-ivivc-needed-in-ndas-fdaers/
- Published: 2016-08-04T12:00:00.000Z
- Updated: 2026-09-14T21:21:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136412

Four CDER staffers say that the drug industry, academia, and regulatory agencies need to make a collaborative effort to develop new approaches and technologies for *in vivo in vitro* correlations (IVIVC) so they can be better used in drug development and post-approval manufacturing changes. [Writing](http://link.springer.com/article/10.1208/s12248-016-9966-2?view=classic&ref=fdaweb.com) in the *AAPS Journal*, published by the American Association of Pharmaceutical Scientists, the four say that in the past two decades, IVIVC has been considered an important tool for supporting biowaivers, setting dissolution acceptance criteria, and in the quality by design framework to promote establishment of clinically meaningful drug product specifications using dissolution as the endpoint.

Based on their FDA review experience, the four say that the overall acceptance rate of IVIVC submissions in the past decade has been 40%. And the number of IVIVC studies seen in the submissions per year has not increased.

“Establishing clinically meaningful drug product specifications through the linkages between the identified critical quality attributes and *in vivo* performance is key for developing a quality drug product,” the article says. “To achieve this goal, there is an imminent need for addressing the issues behind a low success rate in IVIVC development.”

Special considerations should be taken, the authors say, in areas such as **(1)** selection of appropriate number/kind of formulations for IVIVC development/validation; **(2)** construction of exploratory plots to guide model building and selection; **(3)** investigation of the reasons of inclusive predictability; **(4)** improvement in the quality and richness of the data; and **(5)** avoidance of over-parameterization.