Course Description
A continuation of Pharmaceutical Drug Development. Drug substance and drug product stability, tablet coating, and modified release oral dosage forms. Advanced drug delivery systems (transdermal, nanomedicines, gene delivery, protein and peptide delivery, 3D printing) in pharmaceutical and biopharmaceutical drug development. U.S. FDA regulatory submission and approval process for NDA and ANDA will also be discussed.
Additional Requirements for Graduate Students:
Graduate students will be administered different
examinations/assignments that will require them to demonstrate
greater critical thinking skills by applying concepts from the
course in the design and interpretation of experiments.
Athena Title
Adv Drug Delivery Systems
Undergraduate Prerequisite
PMCY 4500/6500 or permission of department
Graduate Prerequisite
PMCY 4500/6500 or permission of department
Semester Course Offered
Offered spring
Grading System
A - F (Traditional)
Course Objectives
This course will critically assess the major issues and stages in drug development, including regulatory, economic, and legal issues associated with the drug development process. In addition, other specialized areas in pharmaceutical and biopharmaceutical drug development, as a continuation of Drug Development I will be discussed. A multidisciplinary perspective will be provided by the faculties representing basic, clinical and management sciences.
Topical Outline
General Regulatory Aspects of Drug Development FDA Approval Process: IND, NDA FDA Interactions: Application Review and Final Approval; Guidance and White Papers Drug Delivery Devices Bioequivalence Testing Small Molecule Therapeutics Large Molecule Therapeutics (Antibodies, Growth Factors, Cytokines, etc.) Scale-up in the Pharmaceutical Industry Biomarkers Post-Market Surveillance Pharmacovigilance and Clinical Data Pathways Pharmacoeconomics Patents and Exclusivity
Syllabus