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Nonclinical Development Of Novel Biologics Biosimilars Vaccines And Specialty Biologics

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Nonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics  Biosimilars  Vaccines and Specialty Biologics Book
Author : Lisa Plitnick,Danuta Herzyk
Publisher : Academic Press
Release : 2013-06-27
ISBN : 0123948231
Language : En, Es, Fr & De

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Book Description :

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

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies Book
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release : 2014-05-02
ISBN : 1118874080
Language : En, Es, Fr & De

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Book Description :

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 models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2016-11-03
ISBN : 0128036214
Language : En, Es, Fr & De

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Book Description :

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 international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and the expectations associated with working in nonclinical toxicology

Regenerative Medicine Technology

Regenerative Medicine Technology Book
Author : Sean V. Murphy,Anthony Atala
Publisher : CRC Press
Release : 2016-11-30
ISBN : 1498711928
Language : En, Es, Fr & De

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Book Description :

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 generated high interest as applications for disease modeling and drug discovery. This book, edited by Drs. Sean Murphy and Anthony Atala, provides a comprehensive coverage of the technologies that have been used to develop organ-on-a-chip systems. Known leaders cover the basics to the most relevant and novel topics in the field, including micro-fabrication, 3D bio-printing, 3D cell culture techniques, biosensor design and microelectronics, micro-fluidics, data collection, and predictive analysis. The book describes specific tissue types amenable for disease modeling and drug discovery applications. Lung, liver, heart, skin and kidney "on-a-chip" technologies are included as well as a progress report on designing an entire "body-on-a-chip" system. Additionally, the book covers applications of various systems for modeling tissue-specific cancers, metastasis, and tumor microenvironments; and provides an overview of current and potential applications of these systems to disease modeling, toxicity testing, and individualized medicine.

Protein Therapeutics

Protein Therapeutics Book
Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
Publisher : John Wiley & Sons
Release : 2017-07-28
ISBN : 3527699139
Language : En, Es, Fr & De

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Book Description :

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 goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.

Genetic Engineering Biotechnology News

Genetic Engineering   Biotechnology News Book
Author : Anonim
Publisher : Unknown
Release : 2009
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Genetic Engineering Biotechnology News book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.