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Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development 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.

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American Society for Clinical Pharmacology & Therapeutics (ASCPT)

Alta Sciences

American Society for Clinical Pharmacology & Therapeutics (ASCPT) iianiro Mon, 01/20/2025 - 21:40 Image ASCPT_GettyImages-1810152596.jpg jpg Synopsis Washington, DC URL [link] Event End Date Sat, 05/31/2025 - 12:00 Event Start Date Wed, 05/28/2025 - 12:00 Weight 1

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Altasciences’ Ophthalmic Expertise: A Conversation with Dr. Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS

Alta Sciences

Altasciences is a forward-thinking drug development solutions company providing pharmaceutical and biotechnology companies with a flexible approach to preclinical and clinical pharmacology studies. This article was posted in April 2025 Image Thumbnail_Blog_Simone and Randy.jpg Tags Preclinical Research Weight 15

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Landiolol

New Drug Approvals

“Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. August 2000). 68 (2): 14350. doi : 10.1067/mcp.2000.108733.

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ATICAPRANT

New Drug Approvals

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Pharmacology Pharmacodynamics Aticaprant is a potent , selective , short-acting (i.e., 2] Aticaprant is taken by mouth. [1]

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

Date What’s Happening Explanation Source June 29 GGP Report FDA expected to finalize report on Good Guidance Practices AgencyIQ June 30 User Fee Payments Industry required to confirm NDA prescription drug products in Orange Book for purposes of PDUFA payments in FY 2025 FDA July 1 Anniversary Anniversary of the signing of the Public Health Service (..)

FDA 40
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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Read our analysis of that rule here and here. ]