Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
September 1, 1997
March 8, 2019
c2ea6b85-0c9d-4fc1-80f0-2b5b1c5dea0e
Related Documents
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act _1
Guidance DocumentJune 15, 1998Center for Drug Evaluation and Research
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for Industry
Guidance DocumentDecember 1, 2000Center for Drug Evaluation and Research
Dissolution Testing of Immediate Release Solid Oral Dosage Forms
Guidance DocumentAugust 25, 1997Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.