Bioequivalence guide

June 17, 2011

THE Therapeutic Goods Administration has adopted a new European Guideline on the Investigation of Bioequivalence.. The TGA has added a note that the EU procedure for abridged applications claiming essential similarity to a reference product within the EU doesn’t apply here. “An application for registration of a generic product in Australia should generally include a bioequivalence study versus a leading brand obtained in Australia,” the note states.

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Pharmacy Daily | Bioequivalence guide

Bioequivalence guide

Other recent headlines

Vape reforms ineffective?

Sleep apnoea to worsen

Choice stands by SPF tests

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES