Dosage Forms, Formulation Developments and Regulations

1. New drug discovery and development
2. Introduction to drugs and different types of dosage forms.
3. Pharmacopoeias, National Formulary and Extra Pharmacopoeias
4. Regulatory affairs: historical overview, authorities and role in drug approval
5. Introduction to intellectual property and patent system
6. WHO and ICH Guidelines for 'Good Manufacturing Practices'
7. Introduction to pharmaceutical validation
8. Design of dosage forms: influences of anatomy and administration routes
9. Formulation strategies to improve the bioavailability of poorly absorbed drugs
10. Optimization techniques in pharmaceutical formulation and processing
11. Pharmaceutical product development: A 'Quality by Design' (QbD) approach
12. Pharmaceutical excipients
13. Pharmaceutical calculations
14. Preformulation considerations in pharmaceutical formulation process
15. Biopharmaceutical classification system (BCS): A strategic tool in pharmaceutical formulation
16. Pilot plant scale up techniques in pharmaceutical product development
17. Technology development and transfer in pharmaceutical product development
18. Recent developments in pharmaceutical liquids
19. Advances in solid dosage forms
20. Advances in semi-solid dosage forms
21. Pharmaceutical sterilization
22. Pharmaceutical sterile formulations
23. Challenges in development and manufacturing for dermatological formulations
24. Pharmaceutical aerosols
25. Pharmaceutical packaging: Recent trends and challenges

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• Tecnologia farmacêutica
• Farmacologia

Drug discovery; drug development; pharmaceutical validation; Formulation; QbD; Biopharmaceutical classification system (BCS)