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Machine Learning‐Based Discovery of a Novel Noncovalent MurA Inhibitor as an Antibacterial Agent

Chemical Biology and Drug Design

Therefore, it is an important target for antibacterial drug research. UDP-N-acetylglucosamine 1-carboxyethylene transferase (MurA) is an important enzyme involved in bacterial cell wall synthesis. Although many MurA inhibitors have been discovered, only fosfomycin is still used as a MurA inhibitor in clinical practice.

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A hybrid evaluation of the intestinal absorption performance of compounds from molecular structure

Chemical Biology and Drug Design

Abstract Intestinal absorption of compounds is significant in drug research and development. The QSPR model accurately predicted the intestinal absorption of molecules, and the computer simulation found the mechanism of molecular structure affecting intestinal absorption.

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Article FDA Thank You FDA’s new guidance explains what to do during a BIMO inspection

Agency IQ

According to the fiscal year 2023 metrics (the most recent available), the BIMO program conducted over 1,000 inspections in FY 2023, with most (779) for CDER-regulated products.

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The Molecular Mechanism of Resveratrol in the Treatment of Chronic Rhinosinusitis Through a Combination of Network Pharmacology and In Vitro Validation

Chemical Biology and Drug Design

Together, the present study systematically clarified the possible mechanisms of RES in the treatment of CRS and provided new ideas for the drug research of this disease. A variety of results from cell experiments verified that RES can effectively inhibit the inflammation, oxidative stress and apoptosis of LPS-induced HNEpCs.

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Article EMA Thank You With all nitrosamines deadlines passed, EMA updates its guidelines

Agency IQ

These API-derived nitrosamines are referred to as Nitrosamine Drug Substance Related Impurities (NDSRIs) and represent an unprecedented development with manufacturing, quality, and product safety implications. In a study of more than 12,000 small molecule drugs , researchers found 40.4%

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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

The problems: Although the current regulation stimulated orphan drug research, it didn’t do enough The regulation fostered development of medicines for rare diseases since implementation, but not enough. Article 81(2)(b) extends data exclusivity by 6 months for medicines addressing an unmet medical need, as orphan drugs do.

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

(ACT EU) / Clinical Trials Coordination Groups (CTCG) 9/11/2024 9/11/2024 Public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimization measures and its Addendum II Webinar ( OPEN ) EMA 9/12/2024 9/12/2024 ENVI meeting Committee meeting ( OPEN ) Environment, Public Health and Food Safety (ENVI) 9/13/2024 9/13/2024 (..)