Temple University 3 credits QARA
This course explores the regulatory and quality assurance issues pertinent to pre-clinical safety research. Research study design and processes will be analyzed by pharmacologic and toxicologic methods and for carcinogenicity and reproductive toxicology. Some time is devoted to mutagenicity and pharmacokinetics, discussed in the context of developing a safety profile and determining the potential risk to humans in subsequent clinical trials. Note: This course fulfills the GxP requirement for M.S. in RA and QA students and for the Drug Development Certificate.
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