Patient Listening Session Summaries
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement…
eCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0
Withdrawn | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have been subsequently withdrawn, and…
Identification of Hexahydrocannabiphorol Metabolites in Human Urine
This paper describes the detection of Phase I and Phase II metabolites of hexahydrocannabiphorol in urine after oral ingestion of…
Metabolic Profile of Etomidate and Its Three Analogs in Zebrafish, Human Liver Microsomes, Human Urine and Hair Samples Using UHPLC‐Q Exactive Orbitrap‐HRMS
Our study researched the metabolism of etomidate and its three analogs in zebrafish, HLMs, human urine and hair samples by…
Methylation of phase II metabolites of endogenous anabolic androgenic steroids to improve analytical performance
Intact phase II metabolites of endogenous anabolic androgenic steroids give important information about metabolism and have the potential to improve…
Is there a relationship between abuse of alcohol and illicit drugs seen in hair results?
Abstract Combined use of alcohol and illicit drugs is a serious health and social problem. In this study, it was…
Trends in exposure to drugs and prohibited substances among sports: A nationwide analysis of 2008–2022 inquiry records
The study collected over 30,000 data points from three major national anti-doping inquiry systems spanning from 2008 to 2022. Approximately…
Development of a method to evaluate the effects of external environments on drug stability in nails using micro‐segmental analysis
An evaluation method using micro-segmental analysis (MSA) of a single nail was developed to examine the effects of external environments…
Development of 3β,4α‐dihydroxy‐5α‐androstan‐17‐one standard solution for doping analyses
In this work, a certified reference material (CRM) for 3β,4α-dihydroxy-5α-androstan-17-one (DHAS), a metabolite of formestane that is used to conceal…