Search Results - "Worden, Mary Alice"

Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS by Hopkins, Seth C., Ogirala, Ajay, Worden, MaryAlice, Koblan, Kenneth S.

“…Background and Objectives In clinical trials, the safety of drugs is summarized by the incidence of adverse events, while post-marketing reporting systems use…”
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A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels by Piacentino, Daria, Ogirala, Ajay, Lew, Robert, Loftus, Gregory, Worden, MaryAlice, Koblan, Kenneth S., Hopkins, Seth C.

“…Introduction Adverse event (AE) data in randomized controlled trials (RCTs) allow quantification of a drug’s safety risk relative to placebo and comparison…”
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A Phase I, Open-Label, Fixed Sequence Study to Investigate the Effect of Cytochrome P450 2D6 Inhibition on the Pharmacokinetics of Ulotaront in Healthy Subjects by Tsukada, Hironobu, Chen, Yu-Luan, Xiao, Guangqing, Lennek, Lisa, Milanovic, Snezana M., Worden, MaryAlice, Polhamus, Daniel G., Chiu, Yu-Yuan, Hopkins, Seth C., Galluppi, Gerald R.

“…Background Ulotaront is a novel psychotropic agent with agonist activity at trace amine-associated receptor 1 (TAAR1) and 5-hydroxytryptamine type 1A (5-HT 1A…”
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A randomized, single‐dose, crossover study of the effects of ulotaront on electrocardiogram intervals in subjects with schizophrenia by Tsukada, Hironobu, Milanovic, Snezana M., Darpo, Borje, Xue, Hongqi, Xiong, Kuangnan, Tripp, Emily, Lennek, Lisa, Worden, MaryAlice, Hopkins, Seth C., Galluppi, Gerald R.

“…This study (NCT04369391) evaluated the effects of ulotaront (SEP‐363856), a novel trace amine‐associated receptor 1 (TAAR1) agonist in development for…”
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EVP-6124, an alpha7 nicotinic acetycholine receptor partial agonist, did not delay cardiac repolarization in healthy subjects by Loewen, Gordon, Gawryl, Maria, Schutz, Ralph, Ngo, Betty, Worden, Mary Alice, Dgetluck, Nancy, Schettler, Jared, Hilt, Dana

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P3–283: EVP‐6124, an alpha7 nicotinic acetycholine receptor partial agonist, did not delay cardiac repolarization in healthy subjects by Loewen, Gordon, Gawryl, Maria, Schutz, Ralph, Ngo, Betty, Worden, Mary Alice, Dgetluck, Nancy, Schettler, Jared, Hilt, Dana

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A dose-optimization trial of laronidase (Aldurazyme ®) in patients with mucopolysaccharidosis I by Giugliani, Roberto, Rojas, Verónica Muñoz, Martins, Ana Maria, Valadares, Eugênia R., Clarke, Joe T.R., Góes, José E.C., Kakkis, Emil D., Worden, Mary Alice, Sidman, Marisa, Cox, Gerald F.

“…Recombinant human α- l-iduronidase (Aldurazyme ®, laronidase) is approved as an enzyme replacement therapy to treat the lysosomal storage disorder,…”
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