Advanced Topics in Pharmaceutical Manufacturing and Regulatory Submissions
PMCY 4510/6510
3 hours
Advanced Topics in Pharmaceutical Manufacturing and Regulatory Submissions
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
Manufacturing and Regulatory
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)
Student Learning Outcomes
Students will describe FDA’s CDER submission process for IND, clinical development, standard vs priority review, and expedited approval pathways for new drug applications (NDA).
Students will understand the regulatory stability submission requirements for drug substances and drug products.
Students will describe and apply drug product development principles for the pre/formulation, manufacturing, and quality control of tablets, tablet coating, delayed-release, and extended-release dosage forms.
Students will explain the major unit operations in oral drug product manufacturing and scale-up.
Students will understand different types of advanced drug delivery for drug targeting, using Transdermal, and Liposomes.
Students will explain recent advances in drug manufacturing – batch vs continuous and 3D Printing.
Students will identify and interpret the Code of Federal Regulations (CFR) and FDA regulatory guidance and requirements for each phase in the new drug application (NDA) process.
