Extended Release Oral Dosage Forms Development Evaluation and Application of in vitroin vivo Correlations Guidance 1997

This guidance provides recommendations to pharmaceutical sponsors who intend to develop documentation in support of an in vitro/in vivo correlation (IVIVC) for an oral extended release (ER) drug product for submission in an NDA or ANDA. The guidance presents a comprehensive perspective on (i) methods of developing an IVIVC and evaluating its predictability; (ii) using an IVIVC to set dissolution specifications; and (iii) applying an IVIVC as a surrogate for in vivo bioequivalence when it is necessary to document bioequivalence during the initial approval process or because of certain pre or postapproval changes (e.g., formulation, equipment, process, and manufacturing site changes).

The topics covered in this guidance are: categories of in vitro/in vivo correlations; general considerations; development and evaluation of a level A in vitro/in vivo correlation; development and evaluation of a level C correlation; and applications of an IVIVC.

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