The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
News|Articles|November 10, 2025
An approach to streamline and simplify the identification of crucial metabolites from targeted protein degraders
Author(s)SCIEX
The identification of drug metabolites is a critical step in drug development due to their impact on drug efficacy and safety. LC-MS platforms provide good selectivity and sensitivity making it the preferred technique for metabolite identification. Here, metabolite identification was performed using unique fragments from EAD and CID spectra. Fragment information from EAD and CID spectra were processed in a single result file to achieve confident structure assignment of and localization of metabolites.
Related to this article
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Trending on Pharmaceutical Technology
1
USP 1074 Revises Excipient Safety: AAPS PharmSci 360 2026
2
AI Formulation: Regulators Want Data
3
AAPS PharmSci 360 2026: IND-Enabling Studies vs Animal Data
4
From URS to Acceptance Evidence: Defining and Testing Interfaces in Pen Injector Assembly
5