ISPE
MARCH 29, 2023
Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.
ISPE
MARCH 29, 2023
Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement.
ISPE
SEPTEMBER 11, 2023
September 2006. AI Technology There are multiple potential future applications of AI technology that can support more efficient technology transfer, scale-up, site monitoring, and regulatory submission processes (see Figure 2). 49 US Food and Drug Administration Center for Drug Evaluation and Research. AAPS Journal 16, no.
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