In this article we try to mention the important guidance and database published by USFDA. Which will help you to utilise the FDA resources more efficiently.
Dissolution Methods Database
For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.
Update frequency: Quarterly
Dissolution Testing of Immediate Release Solid Oral Dosage Forms
In this section you will find the recommendations on dissolution testing, specification setting approach, statistical method and bio waiver status for immediate release oral solid dosage form.
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlation
This guidance provide you the recommendations on method development, dissolution specifications and invivo-invitro correlation (IVIVC) for extended release drug product.
Waiver of InVivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.
This guidance provides recommendation on bio waiver study for immediate release solid dosage form.
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
This guidance provides recommendation on post approval change of the formula, manufacturing site, manufacturing process, scale-up and scale-down of immediate release solid dosage form.
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
This guidance provides recommendation on post approval change of the formula, manufacturing site, manufacturing process, scale-up and scale-down of extended release solid dosage form.
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
This guidance provides recommendation on post approval change of the formula, manufacturing site, manufacturing process, scale-up and scale-down of non sterile semi-solid dosage form.
Inactive Ingredients Search for Approved Drug Products
This database provides the information on inactive ingredients present in USFDA approved drug products. It is helpful for selection of excipients during development.
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