Problem
i. Explain the role CMC Regulatory Affairs professionals have in NDA/BLA supplement preparation.
ii. List four examples of materials that could be described in a Drug Master File.
iii. Discuss the diversity of potential CMC-related postapproval health authority submissions.
iv. Differentiate the various categorizations of US Drug Master Files.
v. Discuss two parameters that may be tested during transport studies, and describe two potential purposes of a forced degradation study.