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D360 UGM 2023 – Presentation Materials

Presentation Title Presenter Roadmap and D360 update David Lowis (Certara) 10 years D360 @ Boehringer Ingelheim Bernd Beck (Boehringer Ingelheim) A D360 Training Journey Frank Kilty (AstraZeneca) The role of D360 in Takeda research data connectivity journey Sean Liu (Takeda) Is Informatics Heaven Found in the Cloud? Jennifer Heymont (Eisai) BioChemUDM: a unified data model … Continued

Pharmacokinetics of Clofarabine in Patients with High-risk Inherited Metabolic Disorders Undergoing Brain-sparing Hematopoietic Cell Transplantation

Clofarabine, a newer purine analog with reduced central nervous system toxicity, may prove advantageous in hematopoietic cell transplantation in patients for whom neurotoxicity is a natural part of disease progression. This study evaluated clofarabine pharmacokinetics in adult and pediatric patients undergoing hematopoietic cell transplantation for the treatment of high-risk, inherited metabolic disorders. Clofarabine (40 mg/m(2)/d) … Continued

The Effect of Plasmapheresis on Blood Pressure in Voluntary Plasma Donors

Donor plasmapheresis involves the removal of a weight-adjusted volume of plasma and the return of cellular components to the donor. Although plasma volume generally returns to normal, some residual effect on vital signs may be possible. This analysis was performed to determine the possible effects of plasmapheresis on blood pressure. A 16-week study was conducted … Continued

Derivation for Logarithmic Trapezoidal AUC Calculation

Calculating area under the curve requires the use of two separate equations: one is follows the “linear trapezoidal rule” and the other follows the “logarithmic trapezoidal rule.” These equations are normally presented in textbooks without derivations so all you have to do is insert the concentrations and times and you can calculate the area under … Continued

Siponimod for Patients with Relapsing-remitting Multiple Sclerosis (BOLD): An Adaptive, Dose-ranging, Randomized, Phase 2 Study

Siponimod is an oral selective modulator of sphingosine 1-phosphate receptor types 1 and type 5, with an elimination half-life leading to washout in 7 days. We aimed to determine the dose-response relation of siponimod in terms of its effects on brain MRI lesion activity and characterize safety and tolerability in patients with relapsing-remitting multiple sclerosis. … Continued
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