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We have detailed in house reports covering the majority of in vitro and in vivo studies conducted to date with brilliant blue and methylene blue (sentinel monitoring), vaccine antigens, and the anthelmintic Ivermectin. Detailed Reports can be made available as required.
The delay of release times in vivo and in vitro have exhibited standard deviations of time of release about the mean release time of generally less than 10%, even at 600 days. Many of the in vitro studies have exhibited a standard deviation of release time of less than 5% of the mean release time. The 'consistency' of the standard deviation at the distinctly different delay of release times is believed to be because of the consistency of the mechanism whereby the coating formulation controls the delay time to release.
In addition to Scientec's own 'in house' data, we are able to cite a considerable body of relevant data from other independent studies (ca. 10,000 data points) using a comparable implant structure, but manufactured using a quite different approach. Scientec personnel were directly involved in the technology development program which generated these data.
A summary of these data are presented in Figures 12 & 13 and in the following Table. The data in Figure 12 shows the in vitro release of device targeted at 60, 95 or 110 day delayed release, while Figure 13 shows the in vitro release from 4 different batches of devices targeting 95 days release. Table provides a comparison of cross 'species' data from the groups of CRD's represented in Figure 13. Overall these studies demonstrate:
Figure 12: Repeatability Data: in vitro release of marker drug from 90 CRD targeted at either 60, 95 or 110 days delayed release.
Figure 13: Reproducibility Data: in vitro release of marker drug by 4 different batched of CRDs, all targeting 95 days delayed release.
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Experimental Code |
in vitro |
Mice
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Sheep
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Sample Population |
Sample Mean (Stdevp) |
Sample Population |
Sample Mean (Stdevp) |
Sample Population |
Sample Mean (Stdevp) |
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LC |
10 |
92 (11) |
100 |
89 (11) |
20 |
96 (7) |
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LD |
10 |
94 (10) |
100 |
95 (10) |
20 |
98 (7) |
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LE |
10 |
85 (2) |
100 |
93 (13) |
20 |
98 (8) |
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LF |
10 |
97 (4) |
100 |
96 (10) |
20 |
100 (5) |
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LG |
10 |
84 (5) |
100 |
114 (10) |
20 |
100 (6) |
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