2021 Clinical Development Clinical Pharmacology Trials 
Cytel
OCTOBER 27, 2023
Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Most of these post-approval changes have been overall decreases in dose.
The Pharma Data
OCTOBER 1, 2021
Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. CESTidentified through 52 weeks of knowledge.
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Agency IQ
SEPTEMBER 15, 2023
The clinical trials underpinning the original determination that phenylephrine is GRASE – that is, Generally Regarded as Safe and Effective – predate the 1994 inclusion of phenylephrine hydrochloride in the final monograph for OTC nasal decongestant drug products. 25 mg)” — such doses had been suggested in the Citizen Petition.
Metabolite Tales Blog
JULY 5, 2023
Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Gangl et al.,
Metabolite Tales Blog
JULY 5, 2023
Still, of the 34 macrocycles currently in clinical trials, only 18% are de novo designed. With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. Gangl et al.,
The Premier Consulting Blog
JUNE 18, 2023
One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.
The Pharma Data
DECEMBER 17, 2020
Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.
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