By John J. Tobin, Gary Walsh
Written in a transparent and concise variety via an skilled writer, this attractively-priced ebook covers regulatory affairs in all significant worldwide markets for prescription drugs and clinical units, making it the main complete in its field.
Following a glance at drug improvement, entire sections are dedicated to nationwide and ecu regulatory concerns, production license program and retention, and law within the united states. different issues handled contain CDER, CBER and advertising and marketing and production licenses, the ICH method and sturdy Laboratory/Clinical/Manufacturing Practices.
every thing pharmacologists, bioengineers, pharma engineers, scholars in pharmacy and people operating within the pharmaceutical want to know approximately clinical regulatory affairs.
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