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08 19 21 -- Top Priorities And Challenges For New CDER Director Patrizia Cavazzoni, M D

08 19 21 -- Top Priorities And Challenges For New CDER Director Patrizia Cavazzoni, M D
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04 23 21 -- Improved Bioavailability In 12 Weeks

04.23.21 Improved Bioavailability In 12 Weeks     An orally disintegrating tablet (ODT) is designed to rapidly dissolve on contact with saliva. This webinar presents the Zydis® ODT technology, a unique freeze-dried tablet, and introduces Zydis Ultra, which incorporates coated APIs for enhanced taste masking at a higher dose strength.   When Trio Medicines’ lead compound showed clinical promise but had limited bioavailability owing to low solubility, an integrated platform with a structured three-step approach substantially enhanced the bioavailability with a limited budget in a tight timeframe.   In this case study, a quality by design (QbD) approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times, making identification and quantitation problematic.

04 21 21 -- Improved Bioavailability In 12 Weeks

04.21.21 Improved Bioavailability In 12 Weeks     An orally disintegrating tablet (ODT) is designed to rapidly dissolve on contact with saliva. This webinar presents the Zydis® ODT technology, a unique freeze-dried tablet, and introduces Zydis Ultra, which incorporates coated APIs for enhanced taste masking at a higher dose strength.   When Trio Medicines’ lead compound showed clinical promise but had limited bioavailability owing to low solubility, an integrated platform with a structured three-step approach substantially enhanced the bioavailability with a limited budget in a tight timeframe.   In this case study, a quality by design (QbD) approach was used to solve a high-performance liquid chromatography (HPLC) analytical method problem where impurity peaks had shifting retention times, making identification and quantitation problematic.

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