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pro vyhledávání: '"Thomas W. Rosanske"'
Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on
Autor:
Kent L. Amsberry, Daniel W. Armstrong, S. Baertschi, James Bergum, Ping Chen, A.M. Clarke, Ian Clegg, Jennifer E. Dally, Vivian A. Gray, Brian L. He, Qin C. Ji, E. Kikovska-Stojanovska, Ryan Klein, Yin Hwa Lai, David K. Lloyd, Myrna A. Monck, Kurt L. Moyer, B. Olsen, John D. Orr, Li Pan, Ernest Parente, R.L. Phelps, George L. Reid, Christopher M. Riley, Thomas W. Rosanske, Michael Ruberto, James R. Scull, Eric B. Sheinin, Pamela A. Smith, Mohsen Talebi, Kailas Thakker, Patrick A. Tishmack, Linna Wang, Qinggang Wang, Harry Yang, Long Yuan
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::472892fa33b35609e7d07fad1966bfdb
https://doi.org/10.1016/b978-0-08-102824-7.01002-2
https://doi.org/10.1016/b978-0-08-102824-7.01002-2
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical produc
In Chapters 2 and 3 Chapter 2 Chapter 3 of this text, the authors have described a process for identifying the critical quality attributes that define specification parameters and acceptance criteria and the approach to developing suitable analytical
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5029a54353aca65bba72b0bf0cfaa08a
https://doi.org/10.1016/b978-0-08-098350-9.00004-7
https://doi.org/10.1016/b978-0-08-098350-9.00004-7
Autor:
Thomas W. Rosanske, Vivian A. Gray
Validation of dissolution methods is the main focus of this chapter. There is a brief overview of the dissolution test and method development. The topics of sampling, filtration, and single-point test versus a dissolution profile are then discussed.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::71f066939d936bd85fc18b8467bbb9e4
https://doi.org/10.1016/b978-0-08-098350-9.00012-6
https://doi.org/10.1016/b978-0-08-098350-9.00012-6
Autor:
Daniel W. Armstrong, James Bergum, Beth Ann Brescia, Peter Bryan, Todd L. Cecil, Ping Chen, Eliza N. Fung, Vivian A. Gray, Brian He, Laureen E. Little, David K. Lloyd, James V. McArdle, Kurt L. Moyer, Bradford J. Mueller, Nilusha L.T. Padivitage, Ernest Parente, Robyn L. Phelps, Shelley R. Rabel Riley, Christopher M. Riley, Thomas W. Rosanske, James Scull, Krzysztof Selinger, Eric B. Sheinin, Pamela A. Smith, Jonathan P. Smuts, Patrick A. Tishmack
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::189c3cdf8d856264725f8cc2505af9d0
https://doi.org/10.1016/b978-0-08-098350-9.01002-x
https://doi.org/10.1016/b978-0-08-098350-9.01002-x