An overview of discovery and development process for biologics / Heather H. Shih, Paula Miller, Douglas C. Harnish --; Nonclinical safety assessment of biologics, including vaccines / Liangbiao George Hu, David W. Clarke --; Clinical assessment of biologics agents / Lesley Ann Saketkoo, Shikha Mittoo, Luis R. Espinoza --; Key regulatory guidelines for development of biologics in the U.S. and Europe / Richard Kingham, Gabriela Klasa, Krista Hessler Carver --; Landscape and consideration of intellectual property for development of biosimilars / Srikumaran Melethil --; Scientific aspects of sterility assurance, sterility, asepsis, and sterilization / James E. Akers and James P. Agalloco --; Cell cell culture processes in monoclonal antibody production / Feng Li, Amy (Yijuan) Shen, Ashraf Amanullah --; Protein/peptide purification and virus reduction / Beckley K. Nfor, Esteban Freydell, and Marcel Ottens --; Chemical and genetic modification / M Farys [and others] --; Analytical characterization of proteins/peptides / Yajun Jennifer Wang and Brian Hosken --; Protein/peptide formulation development / Satoshi Ohtake and Wei Wang --; Regulatory strategies and lessons in the development of biosimilars / Umang S. Shah --; Vaccine development : history, current status, and future trends / Leo Van Der Pol, Jean-Pierre Amorij --; Role and application of adjuvants and delivery systems in vaccines / Rajesh K. Gupta --; Methods for characterizing proteins in aluminum adjuvant formulations / Martinus A.H. Capelle, Emilie Poirier, Tudor Arvinte --; The state of the art and future of gene medicines / Frank Jacobs, Stephanie C. Gordts, Bart De Geest --; Nucleic acid vaccines / Rachel Buglione-Corbett [and others] --; Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer [and others] --; Advent and maturation of regenerative medicine / Abner M. Mhashilkar, Anthony Atala --; Conventional and novel container closure/delivery systems / Joseph Wong, Mahesh V. Chaubal --; Controlled-release systems for biologics / Mayura Oak [and others] --; Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong.
موضوع (اسم عام یاعبارت اسمی عام)
موضوع مستند نشده
Biological products.
موضوع مستند نشده
Biologicals.
موضوع مستند نشده
Drug development.
رده بندی کنگره
شماره رده
QV241
نشانه اثر
.
E358
2014
نام شخص به منزله سر شناسه - (مسئولیت معنوی درجه اول )