When a biological drug patent expires, alternative biosimilar products are developed. Biological drugs are different in many respects from drugs based on chemically synthesized small molecules. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is complicated and difficult. This book 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 post-approval issues.

Quantitative Methods in HIV/AIDS Research provides a comprehensive discussion of modern statistical approaches for the analysis of HIV/AIDS data. The first section focuses on statistical issues in clinical trials and epidemiology that are unique to or particularly challenging in HIV/AIDS research; the second section focuses on the analysis of laboratory data used for immune monitoring, biomarker discovery and vaccine development; the final section focuses on statistical issues in the mathematical modeling of HIV/AIDS pathogenesis, treatment and epidemiology.

This book brings...

Like the well-regarded and bestselling second edition, Sample Size Calculations in Clinical Research, Third Edition, presents statistical procedures for performing sample size calculations during various phases of clinical research and development. This new edition will be updated throughout and will contain four entirely new chapters written especially for this edition.

"A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."