Blog Clinical Development Clinical Pharmacology 
The Premier Consulting Blog
JULY 31, 2024
In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. Listed Drugs [LDs]) and/or published scientific literature.
Alta Sciences
FEBRUARY 8, 2024
The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. View the Driving Simulation Fact Sheet for more information.
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Alta Sciences
OCTOBER 30, 2023
Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read the blog. Read or listen now. Watch the video. Read the fact sheet.
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. 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. Clin Cancer Res 27 (12): 3298–3306.
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.
FDA Law Blog: Drug Discovery
DECEMBER 6, 2024
The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Stay tuned for the next iteration of the Cliffs Notes to the Cliffs Notes.
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