Robert C. Wojcik Setting Dissolution Specifications

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Setting Dissolution Specifications Introduction Setting a s pecification for di ssolution testing is an important part o f the development of a new pharmaceutical. All drug products a rc required to remain wit hin specificatio ns registered with the regulatory agencies of th e cOllntries in whic h these products arc sold, and they must remain so throughout their she lf life. The use of stability studies to predict potency over time is a well-establis hed approach for Setting th e shelf life of a product, but a high pe rce ntage of product recalls a lso in volve failure to re main within limits for di ssolution. Usin g a ratio nal, data- driven approach to Setting the Dissolution specificatio n can reduce uncertainties about product quality and s he lf life.

Setting Dissolution Specifications Introduction Setting a specifica tion for dissolution testing is an important part of the development of a new

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