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|April 4, 2018
PharmTech Q&A Series: Measuring Elemental Impurities in Pharmaceuticals with Rob Thomas, Part 1
Advertisement
In this three-part podcast series, Rob Thomas, principal consultant at Scientific Solutions, discusses the impetus behind his new book, Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide, published on Feb. 2, 2018. The book provides a training tool for novices and inexperienced users of plasma spectrochemistry as well as for supervisors and senior management who want to better understand the analytical issues.
Advertisement
Related to this article
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
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.
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.
Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
FDA grants ravulizumab accelerated approval in IgA nephropathy after a 43.4% proteinuria cut, signaling new IV biologic demand for drug manufacturers.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
Continuous overall equipment effectiveness can be used to pinpoint hidden downtime and process bottlenecks in real time.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA’s New Inspection Playbook Counts Remote Assessments and MRA Reports Toward Facility Evaluations
2
Late-Phase Impurities Need Reference Standards: AAPS PharmSci 360 2026
3
Improving Oral Peptide Delivery Through Structural Modifications
4
Using OEE Monitoring to Justify Expenditure on Aging Production Lines
5