Table of Contents
Demonstrably Difficult to Compound Drug Products
Section 503A(b)(3)(A)
Factors
1. Drug Delivery System
2. Drug Formulation and Consistency
3. Bioavailability
4. Complexity of Compounding
5. Facilities and Equipment
6. Training
7. Testing and Quality Assurance
Factors
Approach
Approach
Approach
Preliminary Findings
Preliminary Findings
Preliminary Findings
Additional Products
PPT Slide
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Author: CDER User
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