ISSDD-3 addresses all aspects of a complex process of advancing a successful drug candidate to the pre-clinical trials and eventually to the market. Both traditional and modern approaches to drug formulation development and corresponding methodologies will also be covered. ISSDD-3 will provide approximately 20 hours of lectures by world-leading experts from both industrial and academic settings. Program will be roughly subdivided into drug development and drug formulation sessions and it will include virtually all topics of relevance to the drug and formulaion development:
- Pharmaceutical development: structure, environment and paradigms
- CMC of pharmaceutical development
- ADME/DPMK, pharmacokinetics and toxicology
- Patent protection and regulatory affairs
- Pharmacogenomics.
- Rational vs. empirical approach to the formulation development
- Product development challenges and strategies
- Choosing the optimal dosage form and routes of administration
- The importance of choosing the optimal solid form of drug. Polymorphs and solvates
- Chemical stability of drug in solid state and in solution
- Physico-chemical and biopharmaceutical profiling. Biopharmaceutical classification system, ionization, lipophilicity, solubility
- Drug absorption and permeability
- Strategies for the development of formulations of poorly soluble drugs
- Excipients and their compatibility
- Formulation development of peptides and proteins
- Analytical methodologies in the formulation development
- Pharmaceutical development: structure, environment and paradigms
- CMC of pharmaceutical development
- ADME/DPMK, pharmacokinetics and toxicology
- Patent protection and regulatory affairs
- Pharmacogenomics.
- Rational vs. empirical approach to the formulation development
- Product development challenges and strategies
- Choosing the optimal dosage form and routes of administration
- The importance of choosing the optimal solid form of drug. Polymorphs and solvates
- Chemical stability of drug in solid state and in solution
- Physico-chemical and biopharmaceutical profiling. Biopharmaceutical classification system, ionization, lipophilicity, solubility
- Drug absorption and permeability
- Strategies for the development of formulations of poorly soluble drugs
- Excipients and their compatibility
- Formulation development of peptides and proteins
- Analytical methodologies in the formulation development
