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.
FDA Law Blog: Drug Discovery
JULY 17, 2024
In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,
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The Premier Consulting Blog
JUNE 8, 2023
In this blog post, we will share valuable strategies and insights for conducting an optimal meeting and navigating the recovery process to get your drug development program back on track if needed. This robust plan will form the foundation of your pre-IND meeting preparation and discussion.
Alta Sciences
FEBRUARY 8, 2024
Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.
Alta Sciences
OCTOBER 30, 2023
Blog : Choosing the Best Bioanalytical Platform for Your Program There are four points to consider when choosing the best bioanalytical platform for your molecule. This informative blog lists crucial points to keep in mind, and details how Altasciences’ experts can help you choose the right platform for you. Read the blog.
New Drug Approvals
DECEMBER 24, 2023
“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1]
The Premier Consulting Blog
NOVEMBER 4, 2023
In general, such meetings are multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), non-clinical, and clinical plans for a development program. In this blog, we share valuable insights and considerations for conducting an optimal assessment in preparation of such meetings from the CMC perspective.
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