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A Practical Guide to Drug Development in Academia

2014-07-08 Medical
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Release : 2014-07-08
Genre : Medical
Kind : eBook
Book Rating : 016/5 ( reviews)

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Book Synopsis A Practical Guide to Drug Development in Academia by : Daria Mochly-Rosen

Download or read book A Practical Guide to Drug Development in Academia written by Daria Mochly-Rosen. This book was released on 2014-07-08. Available in PDF, EPUB and Kindle. Book excerpt: "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 their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."

Guide to Drug Development

2009 Business & Economics
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Release : 2009
Genre : Business & Economics
Kind : eBook
Book Rating : 246/5 ( reviews)

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Book Synopsis Guide to Drug Development by : Bert Spilker

Download or read book Guide to Drug Development written by Bert Spilker. This book was released on 2009. Available in PDF, EPUB and Kindle. Book excerpt: Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards. Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development. Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.

The Patient Group Handbook

2016-01-27
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Release : 2016-01-27
Genre :
Kind : eBook
Book Rating : 103/5 ( reviews)

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Book Synopsis The Patient Group Handbook by : Anthony Hall

Download or read book The Patient Group Handbook written by Anthony Hall. This book was released on 2016-01-27. Available in PDF, EPUB and Kindle. Book excerpt: This new book edited by rare disease experts Anthony Hall and Nicolas Sireau provides a collection of chapters by world leaders in the field of orphan diseases and drugs in order to help patient groups grow fast and sustainably. As a practical, hands-on guide for research and drug development, it provides tools and advice on topics such as: - How to set up and manage a patient group: US and UK perspectives. - How to build an international research consortium. - How to promote basic research. - How to engage with academia for drug discovery. - How to engage with industry. - How to set up a centre of excellence. - New funding strategies for clinical research. - Crowdfunding for rare diseases. - Practical thinking to win bids. - Orphan drug legislation and adaptive licensing. - Early interaction with regulators and parallel scientific advice with health technology assessors. - How to navigate the regulatory process. - Empowering children to become involved in the research agenda. - Natural history studies. - Clinical efficacy measures and surrogate endpoints. - Statistical considerations. - Setting up and running a clinical trial. - Patient registries. - How to interact with government and lobby for change to the clinical trials system. - Patent protection and ownership of patents. - Engaging patients and carers online for clinical trials. If you are involved in patient groups or rare diseases in any way, then this book will provide valuable reading. All royalties from sales of this book are being donated to the charity Findacure, which provides support to rare disease patient groups.

A Practical Guide to Rational Drug Design

2015-10-05 Medical
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Release : 2015-10-05
Genre : Medical
Kind : eBook
Book Rating : 053/5 ( reviews)

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Book Synopsis A Practical Guide to Rational Drug Design by : Sun Hongmao

Download or read book A Practical Guide to Rational Drug Design written by Sun Hongmao. This book was released on 2015-10-05. Available in PDF, EPUB and Kindle. Book excerpt: This book is not going to be an exhaustive survey covering all aspects of rational drug design. Instead, it is going to provide critical know-how through real-world examples. Relevant case studies will be presented and analyzed to illustrate the following: how to optimize a lead compound whether one has high or low levels of structural information; how to derive hits from competitors’ active compounds or from natural ligands of the targets; how to springboard from competitors’ SAR knowledge in lead optimization; how to design a ligand to interfere with protein-protein interactions by correctly examining the PPI interface; how to circumvent IP blockage using data mining; how to construct and fully utilize a knowledge-based molecular descriptor system; how to build a reliable QSAR model by focusing on data quality and proper selection of molecular descriptors and statistical approaches. A Practical Guide to Rational Drug Design focuses on computational drug design, with only basic coverage of biology and chemistry issues, such as assay design, target validation and synthetic routes. Discusses various tactics applicable to daily drug design Readers can download the materials used in the book, including structures, scripts, raw data, protocols, and codes, making this book suitable resource for short courses or workshops Offers a unique viewpoint on drug discovery research due to the author’s cross-discipline education background Explores the author’s rich experiences in both pharmaceutical and academic settings

Global New Drug Development

2014-07-03 Medical
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Release : 2014-07-03
Genre : Medical
Kind : eBook
Book Rating : 853/5 ( reviews)

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Book Synopsis Global New Drug Development by : Jan A. Rosier

Download or read book Global New Drug Development written by Jan A. Rosier. This book was released on 2014-07-03. Available in PDF, EPUB and Kindle. Book excerpt: The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of the drug life cycle, drug development is by far the most crucial part for the initial and continued success of a drug on the market. This book offers an introduction to the field of drug development with a clear overview of the different processes that lead to a successful new medicine and of the regulatory pathways that are used to launch a new drug that are both safe and efficacious. "This is the most comprehensive and detailed book on drug development I have ever read and I feel that it is likely to become a staple of drug development courses, such as those taught at Masters Level in my own University.... I think in the light of increasing integration of company and academic approaches to drug development both sides can read this book... (and, therefore)... this book could not be more timely." —Professor Mike Coleman, University of Aston, UK ( from his review of the final manuscript)

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