Remove Drugs Remove Pharmacokinetics Remove Pharmacy Remove Regulations
article thumbnail

Preparing the next generation of drug discovery scientists

Drug Discovery World

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Starting with the drug. Pharmacokinetics: How the body handles drugs.

article thumbnail

Scalable precision design targeting complex product profiles

Drug Target Review

Given the relevance of brain metastases in cancer patients, what are the pharmacokinetic properties that enable CNS penetration of LSD1 inhibitors? LSD1 demethylates histones which play a critical role in regulating the expression of genes that suppress differentiation and drive the proliferation and survival of several tumour types.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science 40
article thumbnail

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

FDA 40
article thumbnail

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

article thumbnail

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. As more data have been collected on products previously approved, regulators have started to look back at them with a more critical gaze.

FDA 40
article thumbnail

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

Priority A List.

FDA 40