Biosimilar clinical development_ scientific considerations and new method (2017) Pdf Free Download

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This book is a handbook for clinical developers working on biosimilars. It presents state-of-the-art scientific considerations and new methodologies in biosimilar clinical development. It also provides open research problems, questions, and considerations in the area of clinical sciences, statistics, and regulatory sciences.

Biological drug development is on an upward trajectory and a rapidly growing segment in the pharmaceutical industry. On the one hand, biological products have delivered exceptional clinical results, but on the other hand they have introduced high costs to patients and the health care system in the past decade. As a number of top-selling biologic brands are on the verge of losing product patent protection over the next few years, the demand for development and marketing of biosimilars has grown exponentially worldwide. The regulatory, clinical, and statistical research has attracted much attention to the literature in the past few years, and numerous regulatory guidance and scientific papers have been published on biosimilar clinical development. However, very few books are devoted solely to the scientific considerations and methodologies in biosimilar clinical development and this book is designed and constructed to ll this void.

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