Nonclinical 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 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

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  • Author : Lisa Plitnick
  • Publisher : Academic Press
  • Pages : 432 pages
  • ISBN : 0123948231
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKNonclinical Development of Novel Biologics Biosimilars Vaccines and Specialty Biologics

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 : 27 June 2013
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

Comprehensive Toxicology

Comprehensive Toxicology
  • Author : Anonim
  • Publisher : Elsevier
  • Release : 01 December 2017
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

Micro- and Nanotechnology in Vaccine Development

Micro- and Nanotechnology in Vaccine Development
  • Author : Mariusz Skwarczynski,Istvan Toth
  • Publisher : William Andrew
  • Release : 20 September 2016
GET THIS BOOKMicro- and Nanotechnology in Vaccine Development

This book provides a comprehensive overview of how use of micro- and nanotechnology (MNT) has allowed major new advance in vaccine development research, and the challenges that immunologists face in making further progress. MNT allows the creation of particles that exploit the inherent ability of the human immune system to recognize small particles such as viruses and toxins. In combination with minimal protective epitope design, this permits the creation of immunogenic particles that stimulate a response against the targeted pathogen.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
  • Author : Divya Vohora,Gursharan Singh
  • Publisher : Academic Press
  • Release : 14 November 2017
GET THIS BOOKPharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these

Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
  • Author : Iqbal Ramzan
  • Publisher : John Wiley & Sons
  • Release : 03 February 2021
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

Vaccines for Cancer Immunotherapy

Vaccines for Cancer Immunotherapy
  • Author : Nima Rezaei,Mahsa Keshavarz-Fathi
  • Publisher : Academic Press
  • Release : 17 October 2018
GET THIS BOOKVaccines for Cancer Immunotherapy

Therapeutic cancer vaccines represent a type of active cancer immunotherapy. Clinicians, scientists, and researchers working on cancer treatment require evidence-based and up-to-date resources relating to therapeutic cancer vaccines. Vaccines for Cancer Immunotherapy provides a reference for cancer treatment for clinicians and presents a well-organized resource for determining high-potential research areas. The book considers that this promising modality can be made more feasible as a treatment for cancer. Chapters cover cancer immunology, general approaches to cancer immunotherapy, vaccines, tumor antigens, the

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
  • Publisher : National Academies Press
  • Release : 03 April 2011
GET THIS BOOKRare Diseases and Orphan Products

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Preclinical Safety Evaluation of Biopharmaceuticals

Preclinical Safety Evaluation of Biopharmaceuticals
  • Author : Joy A. Cavagnaro
  • Publisher : John Wiley & Sons
  • Release : 07 March 2013
GET THIS BOOKPreclinical Safety Evaluation of Biopharmaceuticals

"The goal is to provide a comprehensive reference book for thepreclinicaldiscovery and development scientist whoseresponsibilities span target identification, lead candidateselection, pharmacokinetics, pharmacology, and toxicology, and forregulatory scientists whose responsibilities include the evaluationof novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictivevalue, lessen the time and cost of launching newbiopharmaceuticals, and speed potentially lifesaving drugs tomarket. This guide covers topics ranging from lead candidateselection to establishing proof of concept and toxicity testing tothe

Choked

Choked
  • Author : Beth Gardiner
  • Publisher : University of Chicago Press
  • Release : 26 April 2019
GET THIS BOOKChoked

Nothing is as elemental, as essential to human life, as the air we breathe. Yet around the world, in rich countries and poor ones, it is quietly poisoning us. Air pollution prematurely kills seven million people every year, including more than one hundred thousand Americans. It is strongly linked to strokes, heart attacks, many kinds of cancer, dementia, and premature birth, among other ailments. In Choked, Beth Gardiner travels the world to tell the story of this modern-day plague, taking

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
  • Publisher : National Academies Press
  • Release : 28 September 2017
GET THIS BOOKPain Management and the Opioid Epidemic

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold

A Practical Guide to Drug Development in Academia

A Practical Guide to Drug Development in Academia
  • Author : Daria Mochly-Rosen,Kevin Grimes
  • Publisher : Springer Science & Business Media
  • Release : 08 July 2014
GET THIS BOOKA Practical Guide to Drug Development in Academia

"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help

In Situ Tissue Regeneration

In Situ Tissue Regeneration
  • Author : Sang Jin Lee,Anthony Atala,James J Yoo
  • Publisher : Academic Press
  • Release : 17 July 2016
GET THIS BOOKIn Situ Tissue Regeneration

In Situ Tissue Regeneration: Host Cell Recruitment and Biomaterial Design explores the body’s ability to mobilize endogenous stem cells to the site of injury and details the latest strategies developed for inducing and supporting the body’s own regenerating capacity. From the perspective of regenerative medicine and tissue engineering, this book describes the mechanism of host cell recruitment, cell sourcing, cellular and molecular roles in cell differentiation, navigational cues and niche signals, and a tissue-specific smart biomaterial system that

Biologics and Biosimilars

Biologics and Biosimilars
  • Author : Congressional Research Service
  • Publisher : Createspace Independent Publishing Platform
  • Release : 13 November 2017
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

Biosimilars

Biosimilars
  • Author : Hiten J. Gutka,Harry Yang,Shefali Kakar
  • Publisher : Springer
  • Release : 13 December 2018
GET THIS BOOKBiosimilars

This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development.

Dictionary of Pharmaceutical Medicine

Dictionary of Pharmaceutical Medicine
  • Author : Gerhard Nahler
  • Publisher : Springer Science & Business Media
  • Release : 29 June 2013
GET THIS BOOKDictionary of Pharmaceutical Medicine

This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of