Bioequivalence and Bioavailability Forum

Hi Compliance,

❝ Kindly advice me on following: How to conduct biostudy of Mirena (levonorgestrel-releasing) Intrauterine System

Yikes. You are a courageous person! That's a nightmare development and I would absolutely seek dialogue with regulators prior to getting too deeply into any study design. With some dependence on the territory you want approval in, your clinical strategy could be dependendent on some silly little non-accessible CMC detail in the dossier of the ref. product.