Mathematical and statistical skills in the biopharmaceutical industry (2020)

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The current book is a product of three authors: the first author (AP) is a mathematician, the second author (OS) is a statistician, and the third author (LBP) is a pharmacologist. As a result, the book is slightly eclectic, since different parts represent views and experiences of different people.

The main subject of the book is application of mathematical and statistical skills in modern clinical drug development (mostly by biostatisticians). Most commonly, the development of new drugs is carried out by pharmaceutical or biotechnology companies. The whole process is a long, expensive, and complex enterprise, which should be performed keeping in mind such aspects as medical ethics, reproducibility and reliability of the results, efficiency in decision making (to maximize return-on-investment), and, of course, compliance with the regulatory standards.

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