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Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. Do you need a pharmacokinetic study?
Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. This article explores the principles, applications and future potential of MSI in drugdevelopment.
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). National Primate Research Centers (NPRCs) Annual Report, 2021. Bailey J, et al.
Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data. This blog was originally published in April 2025.
On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. i] United States Federal Register.
2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] Drug Discovery. nM vs. 24.0 nM vs. 24.0
By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drugdevelopment A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.
Best Practices for Preclinical Dose Range Finding Studies pmjackson Fri, 04/11/2025 - 20:05 Dose range finding (DRF) studies are the foundation of preclinical drugdevelopment, providing crucial information on safety data to assist in the dose level selection before advancing into toxicology studies.
Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Discover how drugdevelopers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15
But according to AgencyIQ’s user fee program performance tracker linked above and the FDA’s PDUFA VII user fee commitments, CDER and CBER committed to perform an “assessment of hiring and retention” with experience in HR operations “to conduct a targeted assessment of the hiring and retention of staff for the human drug review program.”
DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. If FDA meets this timeline, the requirement to submit DAPs for relevant clinical studies would begin around the end of 2025.
estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time.
Finally, CIVMs address some of the unmet needs in drug discovery, including evaluation of drug transport across the foeto-maternal interface and safety assessment of molecules during pregnancy.19 Optimising proteolysis-targeting chimeras (PROTACs) for oral drug delivery: a drug metabolism and pharmacokinetics perspective.
Advancing drug discovery in neuropsychiatric treatment The positive results from the trial are important for the field of drug discovery because they not only highlight the potential of LB-102 as a new and effective treatment for schizophrenia in the U.S,
6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2] Acoramidis was authorized for medical use in the European Union in February 2025. [2] 2] [3] Names During development, acoramidis was known as AG10 (the Alhamadsheh-Graef molecule 10). [20]
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