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By enabling studies to be modified during the course of the trial, modern adaptive clinical trial designs can make studies substantially faster, more efficient, and more powerful than traditional clinical trials. The recent advances in web-based real-time data entry and novel statistical methods have made adaptive clinical trials practical and attractive. Suitable for readers involved in drug development, this is the first book that comprehens...

MP69 was a general algorithm that converted the analog world to encrypted digital forms, primarily used by the Multi-Media companies to control file sharing. But more then an encryption and compression format, it allowed the conversion of any analog data into a full digital simulation. During an archeological dig of an old MP69 data vault, that held thousands of petabytes of MP69 files, human remains where found in a sealed container. Leading ...

By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries.

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Unlike traditional fixed clinical trials that cannot be altered once the study begins, adaptive designs allow the study design to be modified in response to the data being generated in the course of the trial. The newly developed web-based real-time data entry and recent advances in statistical methods have made it possible to perform real-time, adaptive clinical trials. Suitable for readers in academia, industry, and government involved in dr...

Clinical trials are an important part of medicine and healthcare today, 12iding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to st...

Compilation of key regulatory documents for pharmaceutical medicine, including ICH E6, ICH E8, BIMO monitoring manual, 21CFR 50, 54, 56, 312, and 314.