1st Edition

Statistical Design and Analysis in Pharmaceutical Science Validation, Process Controls, and Stability

By Shein-Chung Chow, Jen-pei Liu Copyright 1995
    580 Pages
    by CRC Press

    580 Pages
    by CRC Press

    "Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

    Assay development; assay validation; scaleup design and analysis; USP tests and specifications; process validation; quality assurance; stability studies; accelerated testing; design for long-term stability studies; stability analysis with fixed batches; stability analysis with random batches. Appendices: statistical tables; SAS programs; regulations. references.

    Biography

    Chow, Shein-Chung; Liu, Jen-pei