Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Mohammad Yahyah"'
Publikováno v:
Frontier Star (Pakistan). 09/24/2017.
Publikováno v:
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5320d0b915da9ca563fbd5a6e53d6249
https://doi.org/10.1002/9781119356189.ch4
https://doi.org/10.1002/9781119356189.ch4
Historically, design spaces registered for a pharmaceutical process in a new drug application or similar document were derived from lab scale experimentation. Recently, regulatory agencies such as the Food and Drug Administration (FDA) and the Europe
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::15ada57cd322fa24e1448888d95cd1fd
https://doi.org/10.1016/b978-0-444-63428-3.50378-7
https://doi.org/10.1016/b978-0-444-63428-3.50378-7
Autor:
Maria Concepción Cerrato Oliveros, Sergio Bacchi, Antonella Carangio, Mohammad Yahyah, Arianna Ribecai
Publikováno v:
Organic Process Research & Development. 14:332-338
Classical experimental designs have been used as configurations of choice at GlaxoSmithKline within Chemical Development in establishing robust products and processes while achieving other goals such as reduction of cost, waste, process investigation
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::eb8df12b0f0640e0a569f3dd33c19de6
https://doi.org/10.1021/op900286r
https://doi.org/10.1021/op900286r
Autor:
Mohammad Yahyah, John J. Peterson
Publikováno v:
Statistics in Biopharmaceutical Research. 1:441-449
The ICH Q2 (R1) Guidance on Validation of Analytical Procedures states that a robustness assessment for an analytical method should provide “an indication of its reliability during normal usage.” The concept of “design space” as specified in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::3edb7d36d5c9d5120479eca0ed0d5c65
https://doi.org/10.1198/sbr.2009.0037
https://doi.org/10.1198/sbr.2009.0037
Publikováno v:
Pharmaceutical Statistics. 1:55-58
This paper describes the one-day introduction to experimental design training course at GlaxoSmithKline. In particular, the use of paper helicopter experiments has been an effective and efficient method for teaching experimental design techniques to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::15bd791d627a109c0ff9d94d520cedb4
https://doi.org/10.1002/pst.7
https://doi.org/10.1002/pst.7
Publikováno v:
Frontier Star (Pakistan). 04/11/2018.
Autor:
Peterson, John J.
Publikováno v:
Statistics in Biopharmaceutical Research; Nov2009, Vol. 1 Issue 4, p441-449, 9p
Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the devel
Autor:
Zdravko Kravanja
26th European Symposium on Computer Aided Process Engineering contains the papers presented at the 26th European Society of Computer-Aided Process Engineering (ESCAPE) Event held at Portorož Slovenia, from June 12th to June 15th, 2016. Themes discu