Cytel
OCTOBER 27, 2023
Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. Most of these post-approval changes have been overall decreases in dose. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus.
The Pharma Data
OCTOBER 1, 2021
The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.
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Metabolite Tales Blog
JULY 5, 2023
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. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Gangl et al., Clin Cancer Res 27 (12): 3298–3306.
Metabolite Tales Blog
JULY 5, 2023
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. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. Gangl et al., Clin Cancer Res 27 (12): 3298–3306.
Agency IQ
SEPTEMBER 15, 2023
FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy. billion, compared with retail sales of $0.5
The Premier Consulting Blog
JUNE 18, 2023
Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials.
The Pharma Data
DECEMBER 17, 2020
In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months. EXCELLENCE will evaluate the efficacy and safety of both a single and a repeated dose of TLC599; topline data of TLC’s leading program is expected in the second half of 2021.
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