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Statistics For Biotechnology Process Development
Hardcover

|June 5, 2018

$146.03 online

$180.50list price

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Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies,…
Biosimilars: Regulatory, Clinical, And Biopharmaceutical Development
Hardcover

|December 29, 2018

$191.06 online

$241.50list price

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This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored…
Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

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The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on…
Statistical Methods For Immunogenicity Assessment

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Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and…