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Course No.
:
131701575
Course Name
:
Drug Quality and Regulatory Affairs
Prerequisite
:
131701436
Credit
:
2
Theory credit
:
2
Practical Credit
:
Course Discription
:
This course investigates the current international guidelines and regulatory affairs related to the quality, safety, and efficacy of pharmaceutical dosage forms. It reviews the different guidelines related to the common technical document, test procedures and acceptance criteria for new drug substances and new drug products, Impurities in new drug substances and drug products, stability testing of new drug substances and products, Good Manufacturing Practices, Scale-Up and Postapproval Changes (SUPAC) Regulations, validation of analytical procedures, product development, Quality by Design and quality risk management, and investigation of bioequivalence studies.
Syllabus
:
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The Course offering during the First Semester-2024/2025
Section NO
Theory Section
Teacher
Time & Location
1
0
DR AREEN SULAIMAN MOHAMMAD AL SHWEIAT
17,00 - 19,00 ن / المادة تدرس وجاهي في