Biotechnology, Nanotechnology and Medical Electronics

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Biotechnology, Nanotechnology and Medical Electronics

Biotechnology - Nanotechnology - Medical Device - Medical

Critical Care - Cardiac - Pediatric - Diagnose






Nonclinical Safety Assessment - A Guide To International Pharmaceutical Regulations

RRP $340.99

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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.

It includes:

  • ICH - the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
  • National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia
  • Repeated dose toxicity studies
  • Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology
  • Biotechnology-derived pharmaceuticals
  • Vaccine development
  • Phototoxicity and photocarcinogenicity
  • Degradants, impurities, excipients and metabolites

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.


Pharmaceutical Toxicology In Practice

RRP $277.99

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This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.


Insiders Guide To Getting A Job In Pharmaceutical Sales

RRP $18.99

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"Insiders Guide" to getting a job in pharmaceutical sales. Become a Pharmaceutical Sales Representative Insider tips from one who has real-life experience in pharmceutical sales Earning potential of up to $100,000. Compensation package can include salary, bonus, company car and more!



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Biotechnology, Nanotechnology and Medical Electronics Articles

Biotechnology Nanotechnology Medical Device Medical
Critical Care Cardiac Pediatric Diagnose
Nanotech Diagnostics Pharmaceutical Medical Tech
Biological

Biotechnology, Nanotechnology and Medical Electronics Books

Biotechnology Nanotechnology Medical Device Medical
Critical Care Cardiac Pediatric Diagnose
Nanotech Diagnostics Pharmaceutical Medical Tech
Biological

Biotechnology, Nanotechnology and Medical Electronics

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