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Pharmacokinetic study of the interaction between luteolin and magnoflorine in rats

Chemical Biology and Drug Design

Abstract Both luteolin and magnoflorine have been reported to regulate the development of breast cancer, which makes them easier to co-administrate. Magnoflorine significantly changed the pharmacokinetic profile of luteolin with increased area under the curve (AUC), prolonged t 1/2 , and reduced clearance rate.

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Computational analysis followed by in vitro studies to explore cytokines (TNF??, IL?6 and IL?1?) inhibition potential of the new natural molecule polonilignan

Chemical Biology and Drug Design

Abstract Targeting pro-inflammatory cytokines and their production is found to be of therapeutic benefit for the regulation of inflammation in various chronic autoimmune diseases. Computational analysis and in vitro studies corroborated the cytokines (TNF-α, IL-6 and IL-1β) inhibition potential of the new natural molecule polonilignan.

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Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so. Read the full AgencyIQ analysis here.

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Article FDA Thank You FDA looking to beef up its remote assessments with artificial intelligence

Agency IQ

The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management. In a new contract notice , FDA seeks sources that could furnish “ThinkTrends Software Support for Optical Character Recognition (OCR) PDF Extraction.”

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. This collaboration examining trial formats involved “numerous discussions with regulators, including the US FDA and the EMA Innovation Task Force,” as well as workshops.

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Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans. A big concern for researchers, IRBs and regulators: Diversity beyond race and ethnicity. And this should be done before pen is put to paper to write a clinical study protocol.”Fashoyin-Aje

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Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion. Over the course of the PHE—which spanned more than three years—the FDA used its expanded authority extensively to issue new direct-to-final guidance documents, creating over 80 in total.

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