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pro vyhledávání: '"Diego Zulkiewicz Gomes"'
Autor:
Christopher Day, Fiona King, Diego Zulkiewicz Gomes, Richard E. Jones, Laurence James Harris, Nancy Lewen, Andrew Teasdale, Enid Gatimu, Grace Kocks, Ruth Boetzel, Susana Torres
Publikováno v:
Journal of Pharmaceutical Sciences. 111:1421-1428
The purpose of this publication is to show how an elemental impurities excipient database can be used in assisting the execution of a drug product elemental impurities risk assessment as required by the ICH Q3D guidelines. As a result of this exercis
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 145:414-422
Investigations on the photochemical stability of pharmaceutical substances are mandatory in drug development and licensing as photo-induced degradation of an active pharmaceutical ingredient (API) may not only lead to decreased API concentrations but