Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Written By Lisa Plitnick
Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics
  • Publsiher : Academic Press
  • Release : 27 June 2013
  • ISBN : 0123948231
  • Pages : 432 pages
  • Rating : /5 from reviews
GET THIS BOOKNonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics


Download or read book entitled Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics by author: Lisa Plitnick which was release on 27 June 2013 and published by Academic Press with total page 432 pages . This book available in PDF, EPUB and Kindle Format. Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics
  • Author : Lisa Plitnick,Danuta Herzyk
  • Publisher : Academic Press
  • Release Date : 2013-06-27
  • Total pages : 432
  • ISBN : 0123948231
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Summary : Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while ...

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
  • Author : William J. Brock,Barbara Mounho,Lijie Fu
  • Publisher : John Wiley & Sons
  • Release Date : 2014-05-02
  • Total pages : 560
  • ISBN : 0123948231
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Summary : A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the ...

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2016-11-03
  • Total pages : 986
  • ISBN : 0123948231
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Summary : A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem ...

Regenerative Medicine Technology

Regenerative Medicine Technology
  • Author : Sean V. Murphy,Anthony Atala
  • Publisher : CRC Press
  • Release Date : 2016-11-30
  • Total pages : 428
  • ISBN : 0123948231
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Summary : Miniaturization in the fields of chemistry and molecular biology has resulted in the "lab-on-a-chip." Such systems are micro-fabricated devices capable of handling extremely small fluid volumes facilitating the scaling of single or multiple lab processes down to a microchip-sized format. The convergence of lab-on-a-chip technology with the field of cell ...

Protein Therapeutics

Protein Therapeutics
  • Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
  • Publisher : John Wiley & Sons
  • Release Date : 2017-07-28
  • Total pages : 480
  • ISBN : 0123948231
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Summary : In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics ...

Genetic Engineering Biotechnology News

Genetic Engineering   Biotechnology News
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2009
  • Total pages : 212
  • ISBN : 0123948231
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Summary : Read online Genetic Engineering Biotechnology News written by , published by which was released on 2009. Download full Genetic Engineering Biotechnology News Books now! Available in PDF, ePub and Kindle....