Search Results - "Halvorsen, Mark"

Pharmacokinetics, pharmacodynamics, and safety of USL261, a midazolam formulation optimized for intranasal delivery, in a randomized study with healthy volunteers by Bancke, Lindy L., Dworak, Heather A., Rodvold, Keith A., Halvorsen, Mark B., Gidal, Barry E.

“…Summary Objective To compare the pharmacokinetics, pharmacodynamics, and tolerability of USL261, a midazolam formulation optimized for intranasal delivery,…”
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Comparative steady‐state pharmacokinetic evaluation of immediate‐release topiramate and USL255, a once‐daily extended‐release topiramate formulation by Bialer, Meir, Shekh‐Ahmad, Tawfeeq, Braun, Tricia L., Halvorsen, Mark B.

“…Summary Purpose Compare the pharmacokinetic (PK) profiles of immediate‐ and extended‐release formulations of topiramate (TPM) in healthy subjects following…”
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Once‐daily USL255 as adjunctive treatment of partial‐onset seizures: Randomized phase III study by Chung, Steve S., Fakhoury, Toufic A., Hogan, R. Edward, Nagaraddi, Venkatesh N., Blatt, Ilan, Lawson, Balduin, Arnold, Stephan, Anders, Bob, Clark, Annie M., Laine, Dawn, Meadows, R. Shawn, Halvorsen, Mark B.

“…Summary Objective To evaluate the efficacy and safety of USL255, Qudexy™ XR (topiramate) extended‐release capsules, as an adjunctive treatment for refractory…”
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USL255 extended‐release topiramate: Dose‐proportional pharmacokinetics and tolerability in healthy volunteers by Clark, Annie M., Halvorsen, Mark B., Braun, Tricia L., Johnson, Krista M., Cloyd, James C.

“…Summary Objective Evaluate the pharmacokinetics (PK), safety, and tolerability of single doses of once‐daily USL255, Qudexy XR (topiramate) extended‐release…”
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Comparative pharmacokinetic analysis of USL255, a new once‐daily extended‐release formulation of topiramate by Lambrecht, Lawrence J., Shekh‐Ahmad, Tawfeeq, Todd, Wesley M., Halvorsen, Mark B., Bialer, Meir

“…Summary Purpose:  To compare the pharmacokinetics of USL255, a once‐daily extended‐release (ER) formulation of topiramate (TPM), with Topamax…”
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Pharmacokinetic Comparison of Acetaminophen Elixir Versus Suppositories in Vaccinated Infants (Aged 3 to 36 Months): A Single-Dose, Open-Label, Randomized, Parallel-Group Design by Walson, Philip D., MD, Halvorsen, Mark, PharmD, Edge, James, MS, Casavant, Marcel J., MD, Kelley, Michael T., MD, MPH

“…Abstract Background Because of practical problems and ethical concerns, few studies of the pharmacokinetics (PK) of acetaminophen (ACET) in infants have been…”
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Long-term safety and sustained efficacy of USL255 (topiramate extended-release capsules) in patients with refractory partial-onset seizures by Chung, Steve S, Hogan, R. Edward, Blatt, Ilan, Lawson P., Balduin, Nguyen, Huy, Clark, Annie M, Anders, Bob, Halvorsen, Mark B

“…Abstract Objective The aim of this study was to evaluate long-term safety, efficacy, and quality of life (QOL) of ≤ 400-mg/day USL255, Qudexy® XR (topiramate)…”
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Efficacy of once-daily extended-release topiramate (USL255): A subgroup analysis based on the level of treatment resistance by Hogan, R. Edward, Blatt, Ilan, Lawson, Balduin, Nagaraddi, Venkatesh, Fakhoury, Toufic A, Anders, Bob, Clark, Annie M, Laine, Dawn, Halvorsen, Mark B, Chung, Steve S

“…Abstract Results from a previously conducted global phase III study (PREVAIL; NCT01142193 ) demonstrate the safety and efficacy of once-daily USL255, Qudexy™…”
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Transdermal estradiol gel 0.1% for the treatment of vasomotor symptoms in postmenopausal women by Hedrick, Richard E., Ackerman, Ronald T., Koltun, William D., Halvorsen, Mark B., Lambrecht, Lawrence J.

“…OBJECTIVE:The objective of this study was to evaluate the efficacy and safety of three doses of estradiol gel 0.1% (Divigel, a novel formulation consisting of…”
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Estradiol gel 0.1% relieves vasomotor symptoms independent of age, ovarian status, or uterine status by Hedrick, Richard E., Ackerman, Ronald T., Koltun, William D., Halvorsen, Mark B.

“…OBJECTIVE:Data from a pivotal efficacy trial have been reanalyzed to explore the impact of age, uterine status, and ovarian status on the efficacy of estradiol…”
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Pharmacokinetics of USL261, a Novel Intranasal Formulation of Midazolam, in Subjects with Epilepsy (P3.285) by Bancke, Lindy, Dworak, Heather, Halvorsen, Mark

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Comparison of the Pharmacokinetics of USL255, an Extended-Release Topiramate, When Sprinkled Onto Soft Food or Swallowed Intact (P3.258) by Clark, Annie, Anders, Bob, Halvorsen, Mark

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Generic Antiepileptic Drugs: A Review of Issues Surrounding Formulation Switching (P4.268) by Nguyen, Huy, Clark, Annie, Halvorsen, Mark, Holmay, Mary, Gilmet, Gregory

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Efficacy and Safety of USL255, Qudexy® XR (Topiramate) Extended-Release Capsules, and Second-Generation AEDs (P3.248) by Chung, Steve, Hogan, R. Edward, Blatt, Ilan, Lawson, Balduin, Halvorsen, Mark

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Safety and Pharmacodynamics of USL261, a Novel Formulation of Midazolam Optimized for Intranasal Administration (P02.211) by Dworak, Heather, Bancke, Lindy, Halvorsen, Mark

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Pharmacokinetics of USL261, a Novel Formulation of Intranasal Midazolam (P02.212) by Bancke, Lindy, Dworak, Heather, Halvorsen, Mark

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Long-Term Efficacy of USL255 (Qudexy® XR; Topiramate Extended-Release Capsules) by Refractory Status and Age: PREVAIL OLE (P2.054) by Hogan, Robert, Blatt, Ilan, Holmay, Mary, Nguyen, Huy, Yu, Vincent, Halvorsen, Mark, Chung, Steve

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Neurocognitive Adverse Event Profile of USL255 (Qudexy® XR; Topiramate Extended-Release Capsules): Phase 3 PREVAIL and PREVAIL OLE Studies (P4.222) by Blatt, Ilan, Chung, Steve, Lawson, Balduin, Nguyen, Huy, Yu, Vincent, Holmay, Mary, Halvorsen, Mark, Hogan, Robert

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Development of Unique Dosage Form and Differentiating Features of USL255, Qudexy® XR (Topiramate) Extended-Release Capsules (P2.048) by Chung, Steve, Hogan, Robert, Holmay, Mary, Yu, Vincent, Nguyen, Huy, Blatt, Ilan, Halvorsen, Mark

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Pharmacokinetics, pharmacodynamics, and safety of USL 261, a midazolam formulation optimized for intranasal delivery, in a randomized study with healthy volunteers by Bancke, Lindy L., Dworak, Heather A., Rodvold, Keith A., Halvorsen, Mark B., Gidal, Barry E.

“…Summary Objective To compare the pharmacokinetics, pharmacodynamics, and tolerability of USL 261, a midazolam formulation optimized for intranasal delivery,…”
Get full text