Nonclinical Statistics for Pharmaceutical and Biotechnology Industries, Zhang
Название: Good laboratory practice for nonclinical studies ISBN: 0367336278 ISBN-13(EAN): 9780367336271 Издательство: Taylor&Francis Рейтинг: Цена: 11482.00 р. Наличие на складе: Поставка под заказ.
Описание: This all-encompassing volume addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings
Название: Current Topics in Nonclinical Drug Development ISBN: 0367136279 ISBN-13(EAN): 9780367136277 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The inaugural volume in the Current Topics in Nonclinical Drug Development Series explores the critical issues and current topics in nonclinical drug development. The book will aid toxicologists, toxicologic pathologists, regulators, and study directors, dealing with issues in study design, evaluation of findings, and presentation of data.
Автор: Graham Molineux; MaryAnn Foote; Tara Arvedson Название: Twenty Years of G-CSF ISBN: 3034808046 ISBN-13(EAN): 9783034808040 Издательство: Springer Рейтинг: Цена: 28732.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume in the Milestones in Drug Therapy series describes the past 20 years of treatment with recombinant human G-CSF, including basic science, the use of G-CSF in both the oncology and non-oncology settings, and the safety and economics of its use.
Автор: Howard Fillit, Jefferson Kinney, Jeffrey Cummings Название: Alzheimer`s Disease Drug Development: Research and Development Ecosystem ISBN: 1108838669 ISBN-13(EAN): 9781108838665 Издательство: Cambridge Academ Рейтинг: Цена: 16474.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Provides a definitive overview of the complex ecosystem facilitating Alzheimer`s Disease drug research and development. Demonstrates a drug`s journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.
Автор: Michael Kinch Название: A Prescription for Change: The Looming Crisis in Drug Development ISBN: 1469647575 ISBN-13(EAN): 9781469647579 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 4703.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes--and indeed because of them--our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy.
To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.
Автор: Alagarsamy V. Название: Textbook of Medicinal Chemistry, 3e Vol. 1 (PB) ISBN: 9385915495 ISBN-13(EAN): 9789385915499 Издательство: CBS India Рейтинг: Цена: 5748.00 р. Наличие на складе: Нет в наличии.
Описание: This popular textbook for pharmacy students provides all the information they need to know about medicinal chemistry. The third edition features new layout and design in an attractive two-colour presentation. It contains clear classifications, synthetic schemes, modes of action, metabolism, assay, pharmacological uses with the dose and structure activity relationship (SAR) of the drugs for the various body systems. Contains a complete section on drug design,describing the new drug development. Includes an introduction to the physiological and pathophysiological conditions of diseases and their treatment. Provides well-illustrated synthetic schemes and alternative synthetic routes for the majority of drugs. Additional physico-chemical parameters have been explained.
Описание: Biotechnology, over its relatively brief existence of 40 years, has experienced a mercurial growth. The vast educational need for biotechnology information in this rapidly burgeoning field is a basic rationale here. However a more prominent underpinning is to bring biotech products to market for patients care.
Автор: Rodney Pearlman; Y. John Wang Название: Stability and Characterization of Protein and Peptide Drugs ISBN: 0306443651 ISBN-13(EAN): 9780306443657 Издательство: Springer Рейтинг: Цена: 30039.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume attemptsto provide the formulation scientist with casehistories involving the use of therapeutic proteins and peptides that have been mar- keted or are under clinical testing. In previous volumes of this series, funda- mental theories and principles ofprotein characterization and stability were presented in depth by researchers in their fieldsofexpertise. The way from theory to practice isnot alwaysobvious and straightforward. There isa need for practical examples of how the principles and theories are put into use, specificallyin the development of a pharmaceutical product. It is our hope that this volume will fulfillsuch a need. Itisnot asimple task to choose a panel ofproteinsand peptides from the over 200 agents in human clinical trials. We have tried to collect a wide representation of molecules of different sizes-from 10 amino acids (Leu- prolide) to 1020 amino acids (Muromonab CD3). The examples include agents derived from various sources including monoclonal antibodies (Mur- omonab CD3), recombinant DNA (human and bovine growth hormones), natural source (fibrolase), and chemical synthesis (Leuprolide). Clearly this list is not intended to be encyclopedic. It isthe first time a collection of this sort has been made accessibleto the formulation scientists involved in devel- oping protein and peptide products. Although each chapter in this volume focuses primarily on the charac- terization and stability of a specific molecule, each has unique aspects.
Автор: Carsten Ehrhardt; Kwang-Jin Kim Название: Drug Absorption Studies ISBN: 1489977546 ISBN-13(EAN): 9781489977540 Издательство: Springer Рейтинг: Цена: 39130.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In the last 15 years, a great number of cell- or tissue-based in vitro models have been introduced into the biopharmaceutics arena. These models mimic the different biological barriers that a drug has to overcome to finally reach its target organ/cell/receptor. These in vitro models have been found very useful in not only characterising the permeability behaviour of drugs molecules in epithelial and endothelial tissues, but also studying drug delivery systems for improved delivery and enhanced absorption. Compared to the complex in vivo situation, in vitro models offer a fast, convenient approach with cost advantages most of times. Most importantly, they can be standardised and automatised to be applicable to the high-throughput screening. Starting at the molecular level of studies, continuing with cell monolayer models (both primary and cell lines) and in situ techniques as a final testing format, the book provides a practical approach to contemporary in vitro techniques for drug absorption studies. In addition, chapters on high-throughput assays, in vitro-in vivo correlation, bioinformatics and regulatory issues are covered, giving a comprehensive overview of available models and techniques. Moreover, an appendix comprised with a number of practical protocols is available online, updated as needed, should prove very helpful to apply the techniques directly to the benchside.
Автор: Helmer Erica Название: Pharmaceutical Biotechnology ISBN: 1682861066 ISBN-13(EAN): 9781682861066 Издательство: Неизвестно Цена: 23333.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceutical biotechnology is an expanding field of science and technology which aims to design new therapeutic drugs, diagnose medical irregularities, etc. based on the tools and techniques of biotechnology. The objective of this book is to give a general view of the different areas of pharmaceutical biotechnology, and its applications. It strives to provide a fair idea about this discipline and to help develop a better understanding of the latest advances within tissue culture, bioengineering, drug design and development. While understanding the long-term perspectives of the topics like clinical trials and recombinant DNA technology, the book makes an effort in highlighting their significance as a modern tool for the growth of the discipline. The book is appropriate for students seeking detailed information in this area as well as for experts, and professionals engaged in this field.
Автор: Sarfaraz K. Niazi Название: Biosimilars and Interchangeable Biologics: Strategic Elements ISBN: 1138775509 ISBN-13(EAN): 9781138775503 Издательство: Taylor&Francis Рейтинг: Цена: 16078.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
What's the Deal with Biosimilars?
Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.
Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets.
Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.
Автор: Kim Huynh-Ba Название: Pharmaceutical Stability Testing to Support Global Markets ISBN: 1461425360 ISBN-13(EAN): 9781461425366 Издательство: Springer Рейтинг: Цена: 26120.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book contains the proceedings of the AAPS Stability Workshop. This workshop provides an understanding of the regulatory perspective of stability testing and globally positions the stability program for the 21st century.
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