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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines

By Rebecca Sheets PhD, CAPT (Retired), USPHS, Christopher Hamlin, Susan Neadle, Ivana Knezevic, Mark Schenerman, Mehmet Tosun PhD, Kathryn C. Zoon
Paperback
$150.00
By Rebecca Sheets PhD, CAPT (Retired), USPHS, Christopher Hamlin, Susan Neadle, Ivana Knezevic, Mark Schenerman, Mehmet Tosun PhD, Kathryn C. Zoon
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This second edition of Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switchin...

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Medicine & NursingMedicineBasic SciencesPharmacology