Bioequivalency evaluation by comparison of in vitro dissolution and in vivo absorption using reference equations.

Abstract:

:Using in vitro dissolution and in vivo absorption of different generics or batches for an appropriate drug and dosage form, a reference equation of form: ka = a+bkd+dkd2 can be proposed. In the case of availability of standardised in vitro-in vivo data for a specific drug, a Level A a correlation of this type containing experimentally determined a, b, d parameters would serve to predict in vivo absorption phase of the drug. The larger number of batches, the stronger will be the predictive power of these parameters.

authors

Kayali A

doi

10.1007/BF03188930

subject

Has Abstract

pub_date

1994-07-01 00:00:00

pages

271-7

issue

3

eissn

0378-7966

issn

2107-0180

journal_volume

19

pub_type

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