Understanding and accessing various phases in drug development, including drug discovery, dosage form design and excipients, drug excipient compatibility, manufacturing, and quality control testing of solid oral dosage forms. Types of oral solid dosage forms with emphasis on the immediate release of hard and soft gelatin capsules.
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
Pharm Drug Development
Prerequisite
(PMCY 3200 and PMCY 3300L and PMCY 3500 and PMCY 3800) or permission of department
Semester Course Offered
Offered fall
Grading System
A - F (Traditional)
Student Learning Outcomes
Students will describe the FDA’s mission, organization, and significant US Code of Federal Regulations (CFR) and FDA regulatory guidance’s in the drug application approval process.
Students will differentiate between brand vs generic, prescription vs over-the-counter (OTC), dietary supplements, medical devices, and combination products.
Students will learn different methods of drug discovery, drug substance manufacture and impurities and pharmaceutical salts.
Students will identify the physicochemical and solid-state properties of drugs, including the role of excipients drug absorption in pharmaceutical drug product development.
Students will apply the biopharmaceutical classification system (BCS) and practical pharmaceutical principles necessary for formulation development.
Students will understand drug-excipient compatibility and drug development principles for formulation, manufacturing and quality control of capsule dosage forms.
Students will understand different types of intellectual property and explain the role of patents in drug development.
