PHR 552 - Introduction to the Regulatory Process:Drug Discovery and Development

Institution:

Rush University

Subject:

Description:

Lectures cover drug discovery, the U.S. regulatory process including IND and NDA and clinical trials I through IV. The course also includes lectures on drug metabolism, principles of toxicity, adverse drug reaction reporting, the IRB responsibilities of investigators, biologic and generic drug development, PK/PD modeling, orphan drug development, and medical device approval. [2]

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

WWW.RUSHU.RUSH.EDU

Phone Number:

(312) 942-7100

Regional Accreditation:

North Central Association of Colleges and Schools

Calendar System:

Quarter

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