Biological drug products development and strategies

Biological drug products development and strategies

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Bibliographic Details
Other Authors: Wang, Wei 1957 March 10-, Manmohan Singh 1964 November 8-
Format: Unknown
Published: Hoboken, NJ Wiley c2014
Subjects:
Biological Agents > therapeutic use
Drug Delivery Systems > pharmacology
Drug Discovery
Biological Agents > pharmacology
Online Access:Click Here to View Status and Holdings.
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020 # # |a 9781118148891 (hbk.) 
040 # # |a DNLM  |d ITMB 
060 1 0 |a QV 241 
090 0 0 |a QV241  |b B6155 2014 
245 0 0 |a Biological drug products  |b development and strategies  |c edited by Wei Wang, Manmohan Singh 
260 # # |a Hoboken, NJ  |b Wiley  |c c2014 
300 # # |a xv, 728 p.  |b ill.  |c 25 cm 
504 # # |a Includes bibliographical references and index 
505 1 # |a 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 ... [et al.] -- 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 ... [et al.] -- Multifunctional polymeric nano-systems for RNA interference therapy / Arun Iyer ... [et al.] -- 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 ... [et al.] -- Routes of delivery for biological drug products / Darrell J. Irvine, Xingfang Su, Brandon Kwong. 
650 # 0 |a Biological Agents  |x therapeutic use 
650 # 0 |a Drug Delivery Systems  |x pharmacology 
650 # 0 |a Drug Discovery 
650 # 0 |a Biological Agents  |x pharmacology 
700 1 # |a Wang, Wei  |d 1957 March 10- 
700 # # |a Manmohan Singh  |d 1964 November 8- 
856 4 0 |z Click Here to View Status and Holdings.  |u https://opac.uitm.edu.my/opac/detailsPage/detailsHome.jsp?tid=523920 
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