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|March 18, 2025
Innovations in Linking Rational Design and Material-Sparing Strategies for Enabled Intermediates and Drug Products
Author(s)Lonza
Read about a material-sparing strategy for developing spray-dried intermediates (SDIs) and their tablet formulations, enhancing bioavailability for poorly soluble active pharmaceutical ingredients (APIs), using erlotinib as a case study. By integrating formulation mapping, polymer screening, and compact screening, the approach enables rapid risk identification and informed decision-making for first-round tablet formulations.
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