Statistical applications for chemist...
Burdick, Richard K.

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  • Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Statistical applications for chemistry, manufacturing and controls (CMC) in the pharmaceutical industry/ by Richard K. Burdick ... [et al.].
    其他作者: Burdick, Richard K.
    出版者: Cham :Springer International Publishing : : 2017.,
    面頁冊數: xi, 379 p. :ill., digital ;24 cm.
    內容註: Chapter 1. Introduction -- Chapter 2. Statistical Methods for CMC Applications -- Chapter 3. Process Design: Stage 1 of the FDA Process Validation Guidance -- Chapter 4. Process Qualification: Stage 2 of the FDA Process Validation Guidance -- Chapter 5. GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance -- Chapter 6. Analytical Procedures -- Chapter 7. Specifications -- Chapter 8. Stability -- Chapter 9. Analytical Comparability and Similarity.
    Contained By: Springer eBooks
    標題: Pharmacology - Statistical methods. -
    電子資源: http://dx.doi.org/10.1007/978-3-319-50186-4
    ISBN: 9783319501864
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