Table of Contents
The FDA Process for Approving Generic Drugs
Did you know that generic drugs...
And...
Hatch-Waxman Amendments to FFD&C Act - 1984
Hatch-Waxman Amendments to FFD&C Act - 1984
Office of Generic Drugs
Office of Generic Drugs
Office of Generic Drugs
PPT Slide
What are the requirements for a generic drug?
How do we assure the quality of generic drugs?
PPT Slide
What are the requirements for a generic drug?
Labeling
Chemistry
Examples of Information Covered in a Chemistry Review
Examples of Information Covered in a Chemistry Review
Examples of Information Covered in a Chemistry Review
Examples of Information Covered in a Chemistry Review
Examples of Information Covered in a Chemistry Review
Examples of Information Covered in a Chemistry Review
Manufacturing Compliance Programs
PPT Slide
PPT Slide
B-Rated Drugs
B-Rated Drugs
B-Rated Drugs
Definition of Bioequivalence
PPT Slide
Purpose of BE
Model of Oral Dosage Form Performance
PPT Slide
Plasma Concentration-Dose
Approaches to Determining Bioequivalence (21 CFR 320.24)
Study Designs
Waivers of In Vivo Study Requirements
Statistical Analysis (Two One-sided Tests Procedure)
Statistical Analysis 80 - 125 %
Statistical Analysis
Possible BE Results (90% CI)
Narrow Therapeutic Range (NTI) Drugs
Generic Warfarin 10mg Tablets
PPT Slide
In Vivo Bioequivalence Inspections
Generic Drug Education Program
Physician Focus Group Findings
Getting the Message Out
Educational Program Activities
PPT Slide
PPT Slide
PPT Slide
Generic Drug Education Program Posters
Office of Generic Drugs Center for Drug Evaluation and Research
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