BiologicalsFundamentals of US Regulatory Affairs, Eighth EditionAlix E. Alderman, Pamela Anne Jones, Patricia Anderson, Regulatory Affairs Professionals Society, Alay Bhayani, Clawson Bowman, Evelyn D. Cadman, Rafael Cassata, Melissa Cavuto, Ojas Chandorkar, Min Chen, Joseph C. Fratantoni, Klaus Gottlieb, Michael R. Hamrell, Donna Helms, Nigel A. S. Hernandez, Hutch Humphreys, Treena Jackson, Karen Jaffe, Jocelyn Jennings, Allison Kennedy, William H. Kitchens, Tatiana Leshchinsky, Alan Minsk, Brian Miyazaki, Linda Pollitz, M. Prasad Palthur, Giuseppe Randazzo, Matthew Rycyk, Srikonda Sastry, Anthony P. Schiavone, Jessica W. Smith, Michelle Sotak, Usha Srinivasan, Michael A. Swit, Mya Thomae, Anne Tomalin, Laurence M. Wallman, Maria Walsh, Diane R. Whitworth, Sherry Yanez Gregor, Linda Yang, Andrew P. Zeltwanger, Jeffrey Zinza