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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Book , Date: 15/01/2004
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification and documentation activities and procedural controls required for compliance. The author introduces appropriate supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system life cycle using a structured top-down approach. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
Prices
| Print: | $ 229.95 / £ 115.00 |
Clinical Research and Regulatory Affairs
Journal
Clinical Research and Regulatory Affairs offers research articles that address fresh and original concepts with sound experimental design, methods and interpretation. The journal provides a means of rapid communication of original, scientific and statistically significant results that pertain to advancements in clinical research and regulatory affairs in the areas of drug, device and biological developments.
All subscriptions now include full online access to the complete journal archive!
Click here to find out more about the journal>>
Prices
| Corporate: | € 2,270.00 / £ 1,720.00 / $ 2,840.00 |
| Institutional: | $ 1,395.00 / € 1,115.00 / £ 845.00 |
Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition
Book
In the ten years since the initial publication of Development and Evaluation Drugs from Laboratory through Licensure to Market in 1993, many changes have occurred in biomedicine, biotechnology, pharmaceutical science and technology, and drug evaluation systems. Updated and expanded, this second edition examines all of the recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed and evaluated. Discussions include hot topics such as genome structure, rational drug design, good manufacturing practices, bioavailability and bioequivalence, and Phase IV post-marketing monitoring, and the final chapter explores future challenges.
Prices
| Print: | £ 115.00 / $ 229.95 |
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Book , Date: 23/12/2003
Since the enactment of the first drug law in 1848, the legislation surrounding drug development has evolved into a maze of regulations that can be hard to navigate. Not only are existing regulations constantly reviewed and updated, the increasingly rapid rate of development in the pharmaceuticals field creates new issues that need to be addressed by new legislation. Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics provides a roadmap to the myriad and sometimes confusing regulations that govern this constantly changing field.
Prices
| Print: | $ 199.95 |
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition
Book , Date: 11/08/2008
Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations that apply to human drug and device development, research, manufacturing, and marketing.
Focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and documentation requirements. Draws information from a range of resources, demystifying the inner workings of the FDA and how it operates in terms of compliance and product approval.
This text includes:
• a blueprint to the FDA and drug, biologic, and medical device development
• current, real-time information
• the new drug application (NDA) process
• FDA inspection processes and enforcement options
• expert contributions from companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA
Three new chapters cover:
• clinical trial exemptions
• advisory committees
• provisions for fast track
Prices
| Print: | £ 100.00 / $ 199.95 |
Good Design Practices for GMP Pharmaceutical Facilities
Book , Date: 10/06/2005
A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects - demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.
Prices
| Print: | £ 115.00 / $ 229.95 |
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