John O'Grady – författare

The need for specialist knowledge of the laws governing the regulation of medicines has become apparent. This is the case among not only lawyers but also hospitals, researchers, prescribers and many others involved in the provision of healthcare. Such a need has been precipitated by a number of factors, including the changing structure of healthcare in the UK and Europe and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. However, the information available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book aims to address this situation by bringing together the knowledge of the laws governing the regulation of medicines ranging across the field from the ethics of the use of medicines in treatment and research, through to drug-induced injury, civil liability and no-fault compensation schemes.

Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

Early Phase Drug Evaluation in Man is a comprehensive, practical guide that covers pre-clinical information relevant to early human studies, including pharmaceutical, metabolic, toxicological, and regulatory aspects, as well as the general considerations relevant to all early human studies. Each major therapeutic area is considered by class of activity of drug. The chapters describe what measurements of drug activity are available in healthy human subjects and in patients, how to make the measurements, their value and their limitations. The contributors have been drawn internationally from the pharmaceutical industry and academia. Early Phase Drug Evaluation in Man will provide an important reference guide for industry and academic professionals involved in the development of new drugs.

The need for specialist knowledge of the laws governing the regulation of medicines has become apparent. This is the case among not only lawyers but also hospitals, researchers, prescribers and many others involved in the provision of healthcare. Such a need has been precipitated by a number of factors, including the changing structure of healthcare in the UK and Europe and the various changes in regulation that have arisen both from challenges in the courts and from the intervention of public bodies. However, the information available to those involved in the complex interrelations between medicines, medical devices and the law have remained scarce. This book aims to address this situation by bringing together the knowledge of the laws governing the regulation of medicines ranging across the field from the ethics of the use of medicines in treatment and research, through to drug-induced injury, civil liability and no-fault compensation schemes.