The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action

• প্রধান লেখক: Roger K Verbeeck (লেখক), Flora T Musuamba (লেখক)
• বিন্যাস: গ্রন্থ
• প্রকাশিত: Frontiers Media S.A., 2012-06-01T00:00:00Z.
• বিষয়গুলি: article
• অনলাইন ব্যবহার করুন: Connect to this object online.

On August 1, 2010, a revised guidance regarding bioequivalence (BE) assessment for the approval of innovator (bridging studies, variations, line extensions) and generic medicinal products in the EU came into effect. This revised guideline specifies the requirements for BE assessment for immediate re...