This document discusses applying Quality by Design (QbD) principles for developing a generic version of acetriptan tablets. It involves analyzing the reference listed drug to understand its clinical effects, pharmacokinetics, drug release properties, physicochemical characteristics and composition. This is used to establish a Quality Target Product Profile and identify the Critical Quality Attributes for the generic acetriptan tablets. A risk assessment of the drug substance attributes and excipient compatibility studies are also conducted. Finally, a control strategy is developed for the generic acetriptan tablets to ensure they meet the target product quality standards.

1. QbD for IR Generic Drugs
SIDDU K M
1ST M PHARM
DEPARTMENT OF PHARMACEUTICS
AL AMEEN COLLEGE OF PHARMACY, BENGALURU

2. 1. Analysis of the Reference Listed Drug
Product
1) Clinical
2) Pharmacokinetics
3) Drug Release
4) Physicochemical Characterization
5) Composition

3. 2. Quality Target Product Profile (QTPP) for
Generic Acetriptan Tablets, 20 mg

4. 3. Critical Quality Attributes (CQAs) of Generic
Acetriptan Tablets, 20 mg

5. 4. Risk assessment of the drug substance
attributes

6. 5. Excipient compatibility

8. 6. Control Strategy for Generic Acetriptan
Tablets, 20 mg

10. Thank You