Development and validation of in-vitro assay for the release of estrogen from a lotion
by AAI Pharma Inc.
This white paper by AAI Development Services describes the development and validation of an in-vitro release method for determination of the release of Estrasorb from a lotion. The methodology uses the VanKel enhancer cell and USP apparatus, and was performed per ICH guidelines using the SUPAC-SS guidelines for intermediate precision. The goal of the work is to develop a method to measure the diffusion-controlled release of estrogen from a lotion, validate the method for determination of release of estrogen from lotion and do it according to ICH guidelines.
| Published: | 2006 |
| Format: | |
| Length: | 12 pages |
| Type: | White paper |
| Language: | English |
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