SUPAC guidelines
Submitted by Anonymous on Sun, 07/17/2005 - 22:31
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
SUPAC-IR Questions and Answers about SUPAC-IR Guidance
SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (draft)
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
SUPAC guidelines are FDA guidelines for Scale-Up and Post-Approval Changes for manufacturing of drugs.
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prashant gorasiya
Thu, 09/06/2012 - 10:15
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