The Buccal Route
I came across this paper this week and, although fairly old, it still provides a good overview of the buccal route for systemic drug absorption. All relevant stuff for your formulation & medicinal chemistry modules.
Yet another FDA 483 for compounders
Following on from previous 483s for drug compounders, Speciality Compounding were inspected in March this year and this only came to my attention following their product recall last week. The FDA are now taking some flak for the delay between the 483 and issuing the recall. This 483 should be useful for solid dose trainees as an introduction to poor sterile manufacturing practice.
Patch in a Can
An interesting new development in transdermal drug delivery.
Biobetters Vs Biosimilars
Teva has announced new EU drug approvals for 'biobetters' which apparently improves on the original innovator product on which this new product is based.
South Africa MRA on the Horizon?
Legislative changes in South Africa may provide the potential for future MRAs with EU and FDA
Counterfeit seizure in Ukraine
A large counterfeiting operation has been uncovered in Ukraine.
EMA Paper on Nanotechnology coating
Novel Endotoxin testing
Something new to me this week following some revision of the standard endotoxin tests. This test method is based on bacteriophage binding to LPS and removes the requirement for LAL.
Revised PDA technical report
An updated revision of the PDA's technical report into dry heat sterilisation & depyrogenation methods.
P&G recall
Although for dog food these recalls can still provide useful scenario questions. In this case, what is the potential sources of salmonella, clinical impact of salmonella, microbiology of salmonella etc
Happy reading!
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