A centralized location for accessing information and references to relevant FDA Guidance and USP Chapters for in vitro dissolution testing of immediate release solid oral dosage forms. Very handy and useful resource for anyone in the field of dissolution science.
Resources for Dissolution Testing of IR Solid Oral Dosage Forms
| U.S. Food and Drug Administration |
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| Resources for Dissolution Testing of IR Solid Oral Dosage Forms |
| Compilation of FDA Guidance and Resources for in vitro dissolution method development, validation of dissolution test method, setting in vitro specifications, and CMC documentation to submit for regulatory consideration for in vitro dissolution testing of immediate release solid oral dosage forms. |
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Sandip Tiwari
Head of Technical Services, Pharma Solutions, NA
BASF Corporation
Tarrytown NY
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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