Zobrazeno 1 - 10
of 16
pro vyhledávání: '"Lori B. Pfahler"'
Autor:
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The ta
Autor:
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fdd0ee473409dcf28f126d0b75cc428e
https://doi.org/10.1007/978-3-319-50186-4_6
https://doi.org/10.1007/978-3-319-50186-4_6
Autor:
Richard K. Burdick, Jorge Quiroz, Lori B. Pfahler, David J. LeBlond, Lanju Zhang, Kimberly Vukovinsky, Leslie Sidor
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
This is the first of three chapters that describe statistical approaches related to the three stages of process validation described in the FDA Process Validation Guidance for Industry (2011). The three stages are
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ab80d14e1a121338f2856b7749ec3d19
https://doi.org/10.1007/978-3-319-50186-4_3
https://doi.org/10.1007/978-3-319-50186-4_3
Autor:
Richard K. Burdick, Kimberly Vukovinsky, Lori B. Pfahler, David J. LeBlond, Lanju Zhang, Jorge Quiroz, Leslie Sidor
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
The FDA Process Validation Guidance (2011) advocates Continued process verification Procedure validation a life cycle approach to product manufacturing which ensures the process can reliably and consistently produce quality product that meets the the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::943ea7e3918d0fdc9f79f46c8837c842
https://doi.org/10.1007/978-3-319-50186-4_5
https://doi.org/10.1007/978-3-319-50186-4_5
Autor:
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e0d8586151388cff009f7605ddf4003b
https://doi.org/10.1007/978-3-319-50186-4_1
https://doi.org/10.1007/978-3-319-50186-4_1
Autor:
Kimberly Vukovinsky, Lanju Zhang, Lori B. Pfahler, David J. LeBlond, Richard K. Burdick, Jorge Quiroz, Leslie Sidor
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
In all manufacturing settings, there is an inherent drive to improve product through the reduction in process variation, implementing new technology, increasing efficiency, optimizing resources, and improving customer experience through innovation. I
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::13cd84e5d86fe6a1cfd83973272f230d
https://doi.org/10.1007/978-3-319-50186-4_9
https://doi.org/10.1007/978-3-319-50186-4_9
Autor:
Lanju Zhang, Kimberly Vukovinsky, Leslie Sidor, Jorge Quiroz, Lori B. Pfahler, Richard K. Burdick, David J. LeBlond
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
In Chap. 3, the first stage of the FDA’s 2011 process validation guidance was described demonstrating various options to drive process understanding using experimental design . The resulting process design experiments yield information that can be
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6b7361dfdf6a31e84096c7f99ad46c05
https://doi.org/10.1007/978-3-319-50186-4_4
https://doi.org/10.1007/978-3-319-50186-4_4
Autor:
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c5b99c5325ccea4f87ed38e45e813bb1
https://doi.org/10.1007/978-3-319-50186-4_8
https://doi.org/10.1007/978-3-319-50186-4_8
Autor:
Lori B. Pfahler, David J. LeBlond, Kimberly Vukovinsky, Jorge Quiroz, Richard K. Burdick, Leslie Sidor, Lanju Zhang
Publikováno v:
Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 9783319501840
In this chapter, we provide statistical methods that are useful in CMC applications. Our goal is to provide a description of these methods without delving deeply into the theoretical aspects. References are provided for the reader who desires a more
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fe477bb306a22ad890e5a909c66ddfde
https://doi.org/10.1007/978-3-319-50186-4_2
https://doi.org/10.1007/978-3-319-50186-4_2
Publikováno v:
Journal of Chemical Information and Computer Sciences. 38:305-312
We have developed an algorithm that clusters structural databases using topological similarity. The first step in this procedure is to identify a set of probe structures that all fall outside a defined similarity score cutoff with respect to one anot
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a37fcd7963967daeb3354fe10389d32c
https://doi.org/10.1021/ci970056l
https://doi.org/10.1021/ci970056l
