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|January 27, 2005
Warning Letter
FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.
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The warning cited large-scale compounding of altrenogest, amikacin sulfate, dipyrone, flunixin belumine, ketoprofen, ivermectin, ompeprazole, phenylbutazone, and tripelemine hydrochoride, "among many others." As is typical in these warnings, the agency voiced concerns that Essential is compounding not for individual patients but for third-party resale, and that the compounded drugs duplicate approved products in dosage and concentration.
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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.
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