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New adjunctive antidepressant elevates serotonin in Phase I trial

Drug Discovery World

Evecxia Therapeutics has reported favourable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial of EVX-101 in healthy volunteers treated with escitalopram. The post New adjunctive antidepressant elevates serotonin in Phase I trial appeared first on Drug Discovery World (DDW).

Trials 130
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Drug repurposing: The benefits, risks and what we learned from Covid-19

Drug Discovery World

Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023. Pitceathly argued that interdisciplinary collaboration and good preclinical data is key to successful clinical trials.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Once metabolized, which occurs quickly with a half-life of approximately 1.5

Science 40
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Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Alta Sciences

The trial was performed at Altasciences’ clinical facility in Montréal. The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. Stern, MD, Chief Medical Officer for Ischemix.

Trials 40
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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling. . …

Science 40
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Janssen Presents Results from Phase 3 ACIS

The Pharma Data

Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 Cerebrovascular and Ischemic Cardiovascular Events — In a randomized study (SPARTAN) of patients with nmCRPC, ischemic cardiovascular events occurred in 4% of patients treated with ERLEADA ® and 3% of patients treated with placebo. percent vs. 3.9