Biological drug products development and strategies
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| Other Authors: | , |
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| Format: | Book |
| Published: |
Hoboken, NJ
Wiley
c2014
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| Subjects: | |
| Online Access: | Click Here to View Status and Holdings. |
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| LEADER | 00000n a2200000 a 4501 | ||
|---|---|---|---|
| 001 | wils-523920 | ||
| 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 |
| 964 | # | # | |c BOK |d PH |
CHEMISTRY and PHARMACOLOGY of NATURALLY OCCURRING BIOACTIVE COMPOUNDS