BTEC 3410 - Experimental Design & Analysis: Product Registration and Clinical Trials

Institution:

Kennesaw State University

Subject:

Biotechnology

Description:

This course provides students with an understanding of the methods used in collecting, organizing and managing data as well as an understanding of the concepts involved in Good Manufacturing Practices as related to the biotechnology industry. Issues involving study design, randomization schemes and sample size will be discussed. Operational issues in clinical trials, recruitment of participants, data collection, quality control and data monitoring are also learned. A clinical trial protocol will be written and reviewed as for regulatory submission.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.kennesaw.edu

Phone Number:

(770) 423-6000

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

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