Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions.
Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
<i>Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment</i> explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development.  Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.
Transgenic Plants: A Production System for Industrial and Pharmaceutical Proteins provides a detailed guide to the principles and practice of using transgenic plants as a system for the production of heterologous proteins. It is unique in that it covers the complete process of heterologous protein production in plants, from the initial transformation of the plant, through to transcription, transgene stability and finally the downstreaming processing events for protein purification. Written by an international team of industrialists and academics, this book describes:<br> * the fundamental issues associated with expressing heterologous proteins in plants;<br> * a number of detailed examples of the successful small-and large-scale production of proteins;<br> * the essentials of patenting; and<br> * the commercial exploitation.<br> Transgenic Plants: A Production System for Industrial and Pharmaceutical Proteins will be of interest to plant biotechnologists, molecular biologists and protein biochemists in the biotechnology and pharmaceutical industries.
Biotechnology, Nanotechnology and Medical Electronics Articles
Biotechnology, Nanotechnology and Medical Electronics Books