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 2, 2005
- Pharmaceutical Technology-03-02-2005
- Volume 29
- Issue 3
IPEC-Americas? Updated Significant Change Guide for Bulk Pharmaceutical Excipients
Author(s)Pharmaceutical Technology Editors
IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.
Articles in this issue
over 21 years ago
March 2005over 21 years ago
Packaging Becomes Part of the Prescriptionover 21 years ago
Appraisal of the Laser Diffraction Particle-Sizing Techniqueover 21 years ago
Optimism Taking Over in Pharmaceutical Chemicalsover 21 years ago
In the Spotlight - March 2005over 21 years ago
A “Disclosure Defense” in Liability Lawover 21 years ago
Managing Aseptic Interventionsover 21 years ago
Validating Automated Systemsover 21 years ago
Combination Products Raise Manufacturing ChallengesRelated to this article
This week on PharmTech.com, experts discussed E&L suitability standards, rare disease treatment development, sourcing ingredient suppliers, the use of AI in quality control, and more.
FDA approves GSK's bepirovirsen for chronic hepatitis B after a 19% functional cure rate, raising oligonucleotide scale-up stakes for manufacturers.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
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.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Sanjay Konagurthu, PhD, senior director of Science and Innovation at Thermo Fisher Scientific, explains what teams need to do to ensure the usefulness of AI and what strides have been made with AI in regulatory submissions.
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.