Zobrazeno 1 - 5
of 5
pro vyhledávání: '"Tsae‐Yun Daphne Lin"'
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:
Journal of Pharmaceutical Sciences. 84:1322-1326
Drug stability studies are expensive and time consuming. Multiple batches are studied to ensure that a product will consistently remain within specifications for its entire expiration dating period. Some of these studies involve the same drug product
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::57a04e3fd50ac4f25ee5a3381b19b944
https://doi.org/10.1002/jps.2600841112
https://doi.org/10.1002/jps.2600841112
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:
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