Zobrazeno 1 - 10
of 18
pro vyhledávání: '"Steven A. Zdravkovic"'
Autor:
Steven A. Zdravkovic
Publikováno v:
PDA journal of pharmaceutical science and technology. 75(6)
The assessment of substances that can be extracted (extractables) or leached (leachables) from the materials that come in contact with pharmaceutical products often starts with a general screening of these substances in relevant samples. Although suc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::60c7c850a139b4fa97880a2f5a9fe5fa
https://pubmed.ncbi.nlm.nih.gov/33990421
https://pubmed.ncbi.nlm.nih.gov/33990421
Autor:
Steven A. Zdravkovic
Publikováno v:
PDA journal of pharmaceutical science and technology. 75(1)
A primary mission of the PDA Journal of Pharmaceutical Science and Technology is to disseminate new information pertaining to advancements in the improvement of product quality that ultimately benefit patient health. One such area that is covered by
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d4b18e01a847e1fe062421d3104e0510
https://pubmed.ncbi.nlm.nih.gov/33619224
https://pubmed.ncbi.nlm.nih.gov/33619224
Autor:
Steven A. Zdravkovic
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 73:588-614
Pharmaceutical products come into contact with a diverse range of materials during their manufacture, storage, and administration. As a consequence of this contact, substances can leach from these materials and into the product, which may negatively
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::51ccfc94305a05799edaee136d84276d
https://doi.org/10.5731/pdajpst.2018.009753
https://doi.org/10.5731/pdajpst.2018.009753
Autor:
Steven A. Zdravkovic
Publikováno v:
Pharmaceutical Research. 37
Rubber stoppers that seal the primary packaging systems of parenteral pharmaceutical products have the potential to introduce impurities into the drug during storage. While this interaction has been well characterized for products stored as an aqueou
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1d06c3ee508501566cd83760f5cce160
https://doi.org/10.1007/s11095-020-02805-z
https://doi.org/10.1007/s11095-020-02805-z
Autor:
Steven A. Zdravkovic, Ashley A. Hellenbrand, Alyssa L. Dreger, Cindy T. Duong, Steven R. Duff
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 151:49-60
The analysis of reference standards may be performed to enhance the qualitative and quantitative data generated by non-specific screening methods utilized in extractables studies performed on pharmaceutical contact materials. However, the establishme
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0d588dc1112a50c8841eddc311c4799e
https://doi.org/10.1016/j.jpba.2017.12.054
https://doi.org/10.1016/j.jpba.2017.12.054
Autor:
Steven A. Zdravkovic
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 71:488-501
Lyophilization is commonly used to extend the shelf life of pharmaceutical products which are otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized drug, or other solid medium, to leach or extract substances fr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::90fc04d1b18168bed7ca9d66e089aaee
https://doi.org/10.5731/pdajpst.2016.007468
https://doi.org/10.5731/pdajpst.2016.007468
Autor:
Steven A. Zdravkovic
Publikováno v:
European Journal of Pharmaceutical Sciences. 93:475-483
It has been reported that the presence of polysorbate 80 in a pharmaceutical product's formulation may increase the number and/or amount of impurities leached from materials used during its manufacture, storage, and/or administration. However, it is
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b4c2909ea25180ee26c52ccae884920
https://doi.org/10.1016/j.ejps.2016.08.052
https://doi.org/10.1016/j.ejps.2016.08.052
Autor:
Steven A. Zdravkovic
Publikováno v:
Journal of pharmaceutical sciences. 107(11)
It has been demonstrated that lyophilized drug formulations have an increased propensity to leach substances from the rubber stoppers comprising their primary packaging system when compared to aqueous liquid formulations stored in the same manner. Un
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b4d4d070ce2b1a1a2beadc442df72f19
https://pubmed.ncbi.nlm.nih.gov/30005987
https://pubmed.ncbi.nlm.nih.gov/30005987
Autor:
Steven A. Zdravkovic
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 112
An extractable survey is one of several studies performed on a pharmaceutical storage/delivery system as part of the process of demonstrating that the system is suitable for its intended use. In this paper, a solid phase extraction method for the pre
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2a1f819325c660a7fe7652a1dc2599fd
https://pubmed.ncbi.nlm.nih.gov/25978495
https://pubmed.ncbi.nlm.nih.gov/25978495
Publikováno v:
PDA journal of pharmaceutical science and technology. 68(5)
Pharmaceutical packaging/delivery systems and medical devices are characterized via a controlled extraction study as part of the development process for new pharmaceutical products. The purpose of this study is to determine compounds that may be extr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::226be81fad759c568772a6f65ff1e815
https://pubmed.ncbi.nlm.nih.gov/25336421
https://pubmed.ncbi.nlm.nih.gov/25336421