Tag

Pharmacokinetics

All articles tagged with #pharmacokinetics

healthcare1 month ago•30 min saved

Aquestive gears up for Q3 resubmission after FDA CRL on Anaphylm

Aquestive Therapeutics received an FDA Complete Response Letter for Anaphylm Sublingual Film, with deficiencies limited to human factors and a required PK study; no CMC or broad safety issues were raised. The company plans to revise packaging/instructions, conduct a new HF validation and a PK study in parallel, and target resubmission in Q3 2026. Global filings in Europe and Canada are expected in 2026 as well, and the company remains well-capitalized to support approval and pre-launch activities.

via Stock Titan|

#anaphylm #fda-complete-response-letter #healthcare

health1 year ago•3 min saved

The Role of Skin Color in Medication Effectiveness

Emerging research highlights the impact of skin tone, influenced by melanin levels, on drug efficacy and safety, revealing gaps in current drug development processes. Melanin can alter drug distribution and metabolism, affecting bioavailability and potentially leading to different health outcomes across skin tones. Advances in cell biology, such as 3D cell models and organ-on-a-chip systems, offer tools to study these interactions, but regulatory support and increased diversity in clinical trials are needed to ensure equitable healthcare. New policies aim to improve trial representation and trust among minority groups.

via The Daily Galaxy --Great Discoveries Channel|

#clinical-trials #diversity #drug-development