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The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition continues that tradition. Updated and expanded to reflect the most recent...

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

The realistic portrayals of researching, developing, and ultimately defending the Internet from a malicious "Zero-Day" attack will appeal to every corner of the IT community. Although finctional, the numerous accounts of real events and references to real people will ring true with every member of the security community. This book will also satisfy those not on the "inside" of this community, who are fascinated by the real tactics and motives of criminal, malicous hackers and those who defent the Internet from them.

* The realistic portrayals of researching, developing, and ultimately...