Courses of Instruction

Molecular Pharmacology and Toxicology (MPTX)

MPTX 500 Molecular Pharmacology and Toxicology I (4, Fa) This is the first part of a two-semester introductory and survey course for the molecular pharmacology and toxicology degree program. Prerequisite: knowledge of biochemistry.

MPTX 501 Molecular Pharmacology and Toxicology II (4, Sp) The second part of the two-semester course covers the general aspects of molecular pharmacology and toxicology on the basis of biochemical, molecular, biological and environmental approaches. Prerequisite: MPTX 500.

MPTX 502 Pharmacology (4, Fa) Fundamentals of pharmacology in the context of the rapidly developing knowledge of related disciplines.

MPTX 511 Introduction to Medical Product Regulation (3, Sm) Introduction to regulatory environments surrounding medical product development, manufacturing and marketing; operation of federal, state and international regulatory bodies. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

MPTX 512 Regulation of Pharmaceutical and Biological Products (3, Sm) Ensuring safety and effectiveness of new drugs and biologics; marketing and monitoring approved pharmaceutical/biological products; management of genetically engineered products. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

MPTX 513 Regulation of Medical Devices and Diagnostics (3, Sm) Development and testing of new medical products according to U.S. and international regulatory requirements. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

MPTX 514 Regulation of Food and Dietary Supplements (3, Sm) Regulation and testing of foods, food additives and dietary supplements in the U.S. and abroad. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

MPTX 515 Quality Systems and Standards (3, Sm) Principles of quality assurance and quality control for medical-product development and manufacture. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

MPTX 516 Medical Products and the Law (3, Fa) Legal issues affecting intellectual property, medical product development, marketing and safety, taught through case studies and lectures. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health sciences, engineering or equivalent mix of post-secondary training and industry experience.

MPTX 517 Structure and Management of Clinical Trials (4, FaSpSm) Development and execution of clinical trials: bioethical principles, good clinical practices, project management and documentation.

MPTX 518 Writing Regulatory Drug Submissions (3, Sp) Developing form and content for investigational drug applications, new drug applications, biologic licensing applications to FDA; common technical documents; considerations of writing style.

MPTX 519 Global Regulation of Medical Products (3, Fa) Regulatory requirements governing medical products in European Union, Asia and other global markets.

MPTX 520 Risk Management for Health Care Products (3, Sp) Risk assessment and management techniques, including FMEA, HACCP, HAZAP, human factors analysis; policies, regulations, requirements and standards; loss control and liability prevention.

MPTX 522 Introduction to Clinical Trial Design and Statistics (3) Clinical designs and statistics commonly used to test medical products in general populations and special patient groups.

MPTX 524 Introduction to Food Science and Technology (3, Sm) Discusses the basic and applied concepts of food science and food safety, and demonstrates the principles of food chemistry, sensory evaluation, and product development. Recommended preparation: undergraduate degree in biological sciences or related disciplines.

MPTX 526 Chemistry Manufacturing and Controls (3, Fa) Provides a firm foundation in the domestic and international CMC process, from concept to commercialization of new active pharmaceutical ingredients and products. Recommended preparation: undergraduate degree in pharmacy, medicine or independent health science, engineering or equivalent.

MPTX 531 Cell Biology (4) (Enroll in INTD 531)

MPTX 561 Molecular Genetics (4, Sp) (Enroll in INTD 561)

MPTX 571 Biochemistry (4, Sp) (Enroll in INTD 571)

MPTX 572 Systems Physiology and Disease I (4, Fa) (Enroll in INTD 572)

MPTX 573 Systems Physiology and Disease II (4, Sp) (Enroll in INTD 573)

MPTX 590 Directed Research (1-12, FaSpSm) Research leading to the master’s degree. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.

MPTX 594abz Master’s Thesis (2-2-0, FaSpSm) Credit on acceptance of thesis. Graded IP/CR/NC.

MPTX 599 Special Topics (2-4, max 8) Special topics in Molecular Pharmacology and Toxicology.

MPTX 602 Science, Research and Ethics (2, Fa) A discussion of the unique technological and philosophical issues that challenge modern scientists and a discernment of ethical responses to those challenges.

MPTX 603 Molecular Mechanisms for Biological Signals (4, Fa) Biological mechanisms of hormone, neuro-transmitter, growth factor and xenobiotic actions from ligand-receptor interactions, signal transductions, modification processes to regulation of gene expression and cellular growth. Prerequisite: knowledge of physiology and biochemistry.

MPTX 630 Directed Field-Research Project (6, FaSpSm) Research/policy analysis conducted under preceptor supervision in an industrial or governmental setting. Open to students who have completed the majority of course credits in the Regulatory Science program. Graded CR/NC.

MPTX 700 Seminar in Molecular Pharmacology and Toxicology (1, max 8, FaSp) Contemporary advances in molecular pharmacology and toxicology research. Registration required during each year of residency.

MPTX 790 Research (1-12, FaSpSm) Research leading to the doctorate. Maximum units which may be applied to the degree to be determined by the department. Graded CR/NC.

MPTX 794abcdz Doctoral Dissertation (2-2-2-2-0, FaSpSm) Credit on acceptance of dissertation. Graded IP/CR/NC.