Patient-Reported Outcomes_ Measurement, Implementation and Interpretation (2014) Pdf Free Download

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The focus of this second edition remains those areas of statistics which we regard as most important from a practical perspective in day-to-day clinical pharmacology and related work. It is not intended to be comprehensive but to provide a starting point for those engaged in research. In writing this book we have taken from our own experiences of working in the biopharmaceutical industry. To emphasize this, each chapter begins with a brief vignette from Scott’s experiences updated from the first edition (when appropriate) for more recent experiences. All the sets of data in the book are taken from real trials unless otherwise indicated.

Following a chapter devoted to biopharmaceutical development and clinical pharmacology, describing the general role of statistics, we start with several chapters wholly devoted to the study of bioequivalence – a topic where successful studies are required for regulatory approval. The aim was that this should be, to a large extent, self-contained and mostly at a level that was accessible to those with some statistical background and experience.

In Part II, following a chapter on special topics, we develop two more specialized aspects of bioequivalence testing involving sample size re-estimation followed by a chapter on scaled average bioequivalence.

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