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Early Drug Development
By: Mitchell N. CayeneBook Publisher: John Wiley & Sons
Imprint: Wiley
Format: ePub Encrypted (DRM)
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The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
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| Title of eBook: Early Drug Development | |
| Release Date: 02-25-2011 | |
| Publisher: Wiley |
This eBook download is available in the following formats:
| Parent title | Early Drug Development |
|---|---|
| Encrypted (DRM) | Yes |
| SKU | 9781118035207 |
| File size | 13876 |
| Internet Security | n/a |
| Printing | Not allowed |
| Copying | Not allowed |
| Read aloud | No Sys requirements Download reader |
| Devices | Samsung Tablet, Apple Ipad & Iphone, Barnes & Noble Nook, Kobo eReader, Aluratek Libre, Iliad, Nokia, Blackberry, Hanlin |
| Note | ePub, short for electronic publication is one of our favorites and should be yours for a couple of reasons. ePub offers reflowable text giving you flexibility to manipulate how the content is presented. Moreover, lots of cool features are now being developed for the reader like advanced video and audio. ePub is now an industry standard, so all of the "non-propreitary" hardware manufacturers are now supporting it. |
Early Drug Development
Chapter One
DRUG DISCOVERY AND EARLY DRUG DEVELOPMENTMitchell N. Cayen
1.1 THE DRUG DISCOVERY AND DEVELOPMENT SCENE
1.1.1 Pharmaceutical Research and Development Challenges
Although it is common practice to envisage the launching of a therapeutic as a linear paradigm comprising a drug discovery phase gradually bridging into a development phase, it should be noted that such a process is rarely so straightforward. There are many potential intersecting paths to a successful new therapy, often involving a mixture of successive or concurrent intellectual, scientific, practical, commercial, regulatory, and other considerations among academia, industry, and government. However, for the purposes of the focus of this book, the road to therapeutic success is being presented generally as a linear continuum starting with drug discovery, continuing to drug development, then submission to regulatory agencies and approval, and ending with what is hopefully a high-quality medication that exhibits optimal safety and efficacy in the target population.
Given the achievements in the past several decades in our understanding of the underlying mechanisms of disease, huge technological advances, and the goal of optimizing monetary, staff, and time resources, it would be expected that in the ideal world, in recent years we should have been witnessing an increase in the availability of new and improved medicinal products. However, anyone involved in health care delivery is well aware that this is not the case. The past five years have witnessed a dramatic decline in the number of new drugs approved by the U.S. Food and Drug Administration (
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