Case Study 1
Background
A company had received questions from the EMA concerning the adequacy of a mass balance study / metabolite profiling study and an Absolute Bioavailability study, both of which had used AMS bioanalysis. The EMA asked the company to repeat the studies querying the methodology used
Solution
Garner Consulting reviewed the reports and provided scientific arguments as to the methodology, the adequacy of the data and interpretation of the results
Outcome
The review was submitted to the EMA who accepted Garner Consulting's interpretation and went on to give a Marketing Authorisation for the drug after the client submitted the response together with responses to other EMA queries