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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
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$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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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. This edition provides in-depth coverage of Quality by Design, Combination Products, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflec...

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Medicine & NursingMedicineBasic SciencesPharmacology