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By Russell J. Rackley (auth.), David Young, John G. Devane, Jackie Butler (eds.)

ISBN-10: 1468460366

ISBN-13: 9781468460360

ISBN-10: 1468460382

ISBN-13: 9781468460384

This booklet represents the invited displays and a few of the posters provided on the convention entitled "In Vitro-In Vivo courting (IVIVR) Workshop" held in Sep­ tember, 1996. The workshop was once geared up through the IVIVR Cooperative operating staff which has drawn jointly scientists from a few businesses and associations, either educational and commercial. as well as Elan company, that's a drug supply com­ pany focusing on the advance of ER (Extended free up) dosage varieties, the IVIVR Cooperative operating workforce contains collaborators from the college of Maryland at Baltimore, college university Dublin, Trinity university Dublin, and the collage of no longer­ tingham within the united kingdom. The significant collaborators are: Dr. Jackie Butler, Elan company Prof. Owen Corrigan, Trinity university Dublin Dr. lain Cumming, Elan company Dr. John Devane, Elan company Dr. Adrian Dunne, collage university Dublin Dr. Stuart Madden, Elan company Dr. Colin Melia, collage of Nottingham Mr. Tom O'Hara, Elan company Dr. Deborah Piscitelli, collage of Maryland at Baltimore Dr. Araz Raoof, Elan company Mr. Paul Stark, Elan company Dr. David younger, collage of Maryland at Baltimore the aim of the workshop was once to debate new strategies and strategies within the devel­ opment of in vitro-in vivo relationships for ER items. the unique proposal went again ap­ proximately 15 months ahead of the workshop itself. For your time, the crucial collaborators have been operating jointly on quite a few elements of dosage shape development.

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_. _. · ·•• · . ·· .. _ ·•...... -......... ·• •· o g ·····0···· _. -.. 7 \.. 5 Figure 5. Ninety percent Confidence Regions (CR) of the mean difference in the Ln "Weibull" parameters contrasted with the Similarity Region (SR) boxes. Please note the center of the ellipse and the confidence intervals. 40 P. Sathe et al. deviation box of the similarity region, suggesting similarity of the dissolution profiles of the two standard lots. 2. Meaning of the Ellipse and Its Components From the study of the ellipse, at one glance, a lot of useful information about the dissolution profiles comparison, could be gathered.

Early in development a biostudy was designed to compare a 50 mg tablet, two different formulations of a 100 mg tablet, and a 200 mg tablet at equivalent doses. As shown in Figure 9, a range of about 10% was observed in tablet performance as measured by AUC, but there was no in vitro discrimination between tablet lots. One premise we use is that if differences between formulations are observed in vivo, there should be conditions that can produce similar differences in vitro. The solubility characteristics of the drug made pH the most likely variable to significantly impact the dissolution profiles, so the response of dissolution to pH was measured.

In an in vivo in vitro correlation situation there is (partial) knowledge about the input A(t ) which is obtained from in vitro release experiments. However such knowledge is not complete because of the changing conditions between in-vitro and in-vivo. Given an in-vitro release profile and observations from an individual receiving a similar formulation of drug, the main problem facing the data analyst is to determine how different is the in-vitro release with respect to the in vivo one. An additional aspect of the problem is that the fonts of variability present in the in-vivo and in-vitro release are different.

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In Vitro-in Vivo Correlations by Russell J. Rackley (auth.), David Young, John G. Devane, Jackie Butler (eds.)

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