Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

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  • Publisher : Unknown
  • Release : 04 February 2023
  • ISBN : 012394810X
  • Page : 416 pages
  • Rating : 4.5/5 from 103 voters

Download Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics in PDF, Epub and Kindle

This reference book is devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies, and blood products. It compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating current international regulatory documents.

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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
  • Author : Lisa Plitnick,Danuta J. Herzyk
  • Publisher : Unknown
  • Release Date : 2013
  • ISBN : 012394810X
GET THIS BOOKNonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

This reference book is devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies, and blood products. It compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating current international regulatory documents.

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
  • ISBN : 9780123948236
GET THIS BOOKNonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

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

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
  • ISBN : 9781118874080
GET THIS BOOKThe Role of the Study Director in Nonclinical Studies

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 roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal

Comprehensive Toxicology

Comprehensive Toxicology
  • Author : Anonim
  • Publisher : Elsevier
  • Release Date : 2017-12-01
  • ISBN : 9780081006122
GET THIS BOOKComprehensive Toxicology

Comprehensive Toxicology, Third Edition, discusses chemical effects on biological systems, with a focus on understanding the mechanisms by which chemicals induce adverse health effects. Organized by organ system, this comprehensive reference work addresses the toxicological effects of chemicals on the immune system, the hematopoietic system, cardiovascular system, respiratory system, hepatic toxicology, renal toxicology, gastrointestinal toxicology, reproductive and endocrine toxicology, neuro and behavioral toxicology, developmental toxicology and carcinogenesis, also including critical sections that cover the general principles of toxicology, cellular and

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
  • ISBN : 9780128036211
GET THIS BOOKA Comprehensive Guide to Toxicology in Nonclinical Drug Development

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 cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of

Translational Medicine

Translational Medicine
  • Author : Joy A. Cavagnaro,Mary Ellen Cosenza
  • Publisher : CRC Press
  • Release Date : 2021-11-26
  • ISBN : 9781000471823
GET THIS BOOKTranslational Medicine

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for

Regenerative Medicine Technology

Regenerative Medicine Technology
  • Author : Sean V. Murphy,Anthony Atala
  • Publisher : CRC Press
  • Release Date : 2016-11-30
  • ISBN : 9781498711920
GET THIS BOOKRegenerative Medicine Technology

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 biology facilitated the development of "organ-on-a-chip" systems. Such systems simulate the function of tissues and organs, having the potential to bypass some cell and animal testing methods. These technologies have

Challenges in Protein Product Development

Challenges in Protein Product Development
  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher : Springer
  • Release Date : 2018-06-20
  • ISBN : 9783319906034
GET THIS BOOKChallenges in Protein Product Development

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein

Protein Therapeutics

Protein Therapeutics
  • Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
  • Publisher : John Wiley & Sons
  • Release Date : 2017-07-28
  • ISBN : 9783527699131
GET THIS BOOKProtein Therapeutics

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 market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing
  • Author : Ganapathy Subramanian
  • Publisher : John Wiley & Sons
  • Release Date : 2015-02-09
  • ISBN : 9783527335954
GET THIS BOOKContinuous Processing in Pharmaceutical Manufacturing

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals
  • Author : Huss Ralf,Guenther Christine,Hauser Andrea Josefine
  • Publisher : World Scientific
  • Release Date : 2015-09-23
  • ISBN : 9789814616805
GET THIS BOOKAdvances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins
  • Author : Honghui Zhou,Frank-Peter Theil
  • Publisher : John Wiley & Sons
  • Release Date : 2015-10-26
  • ISBN : 9781118898802
GET THIS BOOKADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve

Biologics and Biosimilars

Biologics and Biosimilars
  • Author : Congressional Research Service
  • Publisher : Createspace Independent Publishing Platform
  • Release Date : 2017-11-13
  • ISBN : 1979692319
GET THIS BOOKBiologics and Biosimilars

A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation. A biosimilar, sometimes referred to as a follow-on biologic, is a

Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
  • Author : Iqbal Ramzan
  • Publisher : John Wiley & Sons
  • Release Date : 2021-02-03
  • ISBN : 9781119564652
GET THIS BOOKBiologics, Biosimilars, and Biobetters

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such

Safety of Biologics Therapy

Safety of Biologics Therapy
  • Author : Brian A. Baldo
  • Publisher : Springer
  • Release Date : 2016-08-12
  • ISBN : 9783319304724
GET THIS BOOKSafety of Biologics Therapy

This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins