CBE 563 - Dev&manuf of Biopharm

Institution:

University of Pennsylvania

Subject:

Description:

New drug development and regulatory compliance related to small molecules and biologics, overview of biopharma industry, regulation and development process for new chemical entities and biolgies, formulation of pharmaceutical dosage forms, current Good Manufacturing Practices, chemistry manufacture and controls, overview of Common Technical Document (CTD), managing post-approval changes - formulatin, process, packaging, and analytical.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.upenn.edu

Phone Number:

(215) 898-5000

Regional Accreditation:

Middle States Association of Colleges and Schools

Calendar System:

Semester

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