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Publisher Summary The purpose of this chapter is to discuss various aspects of in vitro drug release test method development, optimization, and validation. It discusses both compendia and non-compendia methods and provides suggestions to achieve sound, scientific development, and validation for such methods. A controlled release veterinary pharmaceutical is specifically designed to release its contents over an extended period at a predefined rate. The release characteristics of the product are dependent upon its formulation and the process conditions used during its manufacture. Manufacturers need some method that allows them to determine the effect of formulation and manufacturing variables on release rate. It is important to develop an inexpensive, rapid, and reproducible test that assesses the drug release characteristics of the product in vitro, but which provides assurances to manufacturers and regulatory bodies of the batch-to-batch in vivo performance of the product. |
