[PDF.83pa] Global Clinical Trials for Alzheimer’s Disease: Chapter 8. The Regulatory Environment Surrounding Alzheimer’s Disease Research: FDA and EMA Guidance

Global Clinical Trials for Alzheimer’s Disease: Chapter 8. The Regulatory Environment Surrounding Alzheimer’s Disease Research: FDA and EMA Guidance

[PDF.lc36] Global Clinical Trials for Alzheimer’s Disease: Chapter 8. The Regulatory Environment Surrounding Alzheimer’s Disease Research: FDA and EMA Guidance

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 |  2013-08-28 |  2013-08-28 | File type: PDF

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Data from clinical trials in emerging markets are becoming a standard component of the regulatory package being provided to support pharmaceutical marketing authorizations including the FDA New Drug Application (NDA) and the EMA Marketing Authorization Application (MAA). In this chapter, the highlights of the requirements for Alzheimer’s disease interventions are summarized, including a review of trial enrichment strategies. The topic of acceptance of foreign clini...

You easily download any file type for your gadget.Global Clinical Trials for Alzheimer’s Disease: Chapter 8. The Regulatory Environment Surrounding Alzheimer’s Disease Research: FDA and EMA Guidance   |  Muriel O' rne, Menghis Bairu. I really enjoyed this book and have already told so many people about it!

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