EVENT | 2nd BIOEQUIVALENCE WORKSHOP

The workshop will provide a platform for an exchange of views between industry, regulators and academia.

The workshop will provide a platform for an exchange of views between industry, regulators and academia.
April 25, 2023

Join our expert, Lidia Cánovas, at the 2nd Bioequivalence workshop that will take place in Brussels tomorrow!

While regional public consultations on the draft of the Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms text take place, leading international experts will gather tomorrow for an exchange of topics at Medicines for Europe workshop.

Join Lidia in Brussels by sending an email at: [email protected] and do not hesitate reaching out to Asphalion for any regulatory need!

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NEWS | Important Update from the FDA!

This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.

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