Dissolution Testing of Immediate Release Solid Oral Dosage Forms
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dissolution Testing of Immediate Release Solid Oral Dosage Forms.'' The purpose of this guidance document is to provide general recommendations for dissolution testing, approaches for setting dissolution specifications related to biopharmaceutic characteristics of the drug substance, statistical methods for comparing dissolution profiles, and a process to help determine when dissolution testing is sufficient to grant a waiver for an in vivo bioequivalence study. This guidance document also provides recommendations for dissolution tests to help ensure continuous drug product quality and performance after certain postapproval manufacturing changes.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 97D-0331.