Transcription of Robert C. Wojcik Setting Dissolution Specifications
{{id}} {{{paragraph}}}
Example: air traffic controller
Robert C. Wojcik Setting Dissolution Specifications
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
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Related search queries
Specification, Testing, Ich harmonised tripartite guideline, CRITERIA, Dissolution, Dissolution Technique to Assess Generic Formulation Differences, Stability Testing of Dietary Supplements, DECISION TREE, General guidance on hold‑time studies, Quality of oral modified release, Quality of oral modified release products, Stability – Regulatory Requirements