Zobrazeno 1 - 10
of 32
pro vyhledávání: '"CHI-WAN CHEN"'
Autor:
Lori McCaig, Alexander Abbott, Cherokee Hoaglund-Hyzer, Andrew Lennard, Fenghe Qiu, Jenny Carhart, Mingkun Fu, Robert J. Timpano, Tony Mazzeo, Yelizaveta Babayan, Chad Nolan Wolfe, Dennis Stephens, Elke Debie, Megan McMahon, Sylvine Pischel, Kayla Woodlief, Debra Webb, Yan Wu, Hanlin Li, Chi-wan Chen
Publikováno v:
The AAPS Journal. 23
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::43a0c51e112b56e2b17e7cfd2e7b4b93
https://doi.org/10.1208/s12248-021-00646-1
https://doi.org/10.1208/s12248-021-00646-1
Autor:
Cherokee Hoaglund-Hyzer, Mingkun Fu, Alexander Abbott, Megan McMahon, Sylvine Pischel, Lori McCaig, Chi-wan Chen, Jenny Carhart, Kayla Woodlief, Andrew Lennard, Dennis Stephens, Yan Wu, Debra Webb, Fenghe Qiu, Robert J. Timpano, Hanlin Li, Tony Mazzeo, Elke Debie, Yelizaveta Babayan, Chad Nolan Wolfe
Publikováno v:
The AAPS Journal. 23
In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::731bc556aaab25ec8ed805c05e69f648
https://doi.org/10.1208/s12248-021-00641-6
https://doi.org/10.1208/s12248-021-00641-6
Publikováno v:
Journal of Biopharmaceutical Statistics. 13:431-449
In a regular analysis of covariance (ANCOVA) approach to stability analysis, the decision for pooling data from different batches plays a key role in the determination of the shelf life of the drug product. Conventionally, the decision to pool data f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3664fa00186191ea3b27c92c7da88023
https://doi.org/10.1081/bip-120022765
https://doi.org/10.1081/bip-120022765
Publikováno v:
Encyclopedia of Biopharmaceutical Statistics ISBN: 1439822468
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::191dc5e05872f697da76fa4183bb899d
https://doi.org/10.3109/9781439822463.015
https://doi.org/10.3109/9781439822463.015
Autor:
Tsae‐Yun Daphne Lin, Chi Wan Chen
Publikováno v:
Encyclopedia of Statistical Sciences
A good stability study design is the key to a successful stability program. In this article, stability designs including full, bracketing, and matrixing designs will be exemplified. A full design involves complete testing of all factor combinations a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6fd642b84c7246fb80ea830279ef6721
https://doi.org/10.1002/9780471462422.eoct002
https://doi.org/10.1002/9780471462422.eoct002
Autor:
Gil Jong Kang, Lucinda F. Buhse, Richard E. Kolinski, Arthur Kibbe, Saleh A Turujman, Benjamin J. Westenberger, Brian Heintzelman, Chi Wan Chen, Eric Wolfgang, John A. Spencer, Mamta Gautam-Basak, Anna M. Wokovich
Publikováno v:
International journal of pharmaceutics. 295(1-2)
Current definitions of lotions, gels, creams and ointments vary depending on literature source, market history or traditional use. This often leads to confusion when deciding which dosage form to prescribe and/or purchase. The existing classification
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::00a1c7b916c64d30c4b53d9f699d6a09
https://pubmed.ncbi.nlm.nih.gov/15847995
https://pubmed.ncbi.nlm.nih.gov/15847995
Publikováno v:
Journal of biopharmaceutical statistics. 13(3)
For a traditional multiple batch stability design with no other factor, the conventional analysis is analysis of covariance (ANCOVA) modeling using F-tests based on type I sum of squares to determine whether the batches may be pooled for a common est
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2f5491b6aaa14a12526aed0fb3d08b10
https://pubmed.ncbi.nlm.nih.gov/12921388
https://pubmed.ncbi.nlm.nih.gov/12921388
Autor:
Chi Wan Chen, Tsae-Yun Daphne Lin
Publikováno v:
Journal of biopharmaceutical statistics. 13(3)
Stability requirements for the worldwide registration of pharmaceutical products have changed dramatically in the past few years. A series of guidelines on the design, conduct, and data analysis of stability studies of pharmaceuticals have been publi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::58c3108eb16195ab9a4365c33aceba15
https://pubmed.ncbi.nlm.nih.gov/12921386
https://pubmed.ncbi.nlm.nih.gov/12921386
Publikováno v:
Antisense research and development. 3(4)
It is important to remember that while a new class of therapeutic agents like oligonucleotides may introduce novel concerns, the basic regulatory issues regarding the chemistry, manufacturing, and controls of drug substances and drug products must be
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::da5e98d60285e8553e251da1dadf109b
https://pubmed.ncbi.nlm.nih.gov/8155982
https://pubmed.ncbi.nlm.nih.gov/8155982