CHEM 478 - Pharmaceutical Development

Institution:

California Polytechnic State University-San Luis Obispo

Subject:

Description:

Process of drug development from research clinical candidate to market. Chemical process development, including synthesis optimization, scale up, pilot plant work, manufacturing, and good manufacturing procedure (GMP's). Role of pharmaceutics in drug development, including various forms of formulation, analytical development requirements, and quality assurance. Project planning and timeline management, clinical trials, and regulatory affairs, including FDA filings. 3 lectures. Prerequisite: CHEM 318.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.calpoly.edu

Phone Number:

(805) 756-1111

Regional Accreditation:

Western Association of Schools and Colleges

Calendar System:

Quarter

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