Track 15: Novel Drug Delivery System
“Novel Drug delivery System (NDDS) refers to the approaches, formulations, technologies, and systems for transporting apharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects. Optimizing the therapeutic effect of the drug on the body (pharmacodynamics) and the body on the drug (pharmacokinetics) has produced an alternative group of products designed to achieve specialized delivery and/or disposition of drugs. A toxic drug may be used in more effective concentrations by targeting the drug to its site of action and decreasing additional systemic toxicity. Four possible regulatory situations for delivery system and drug have been identified, and generalizations regarding the non-clinical studies needed for the initiation of clinical trials and New Drug Application (NDA) have been described.
Track 15-1 Drug Carriers
Track 15-2 New Drug Application
Track 15-3 Future Opportunities & Challenges
Track 15-4 Biodegradability & Biocompatibility
Track 15-5 Advantage / Disadvantage of Drug Delivery System