CASE STUDIES

Examples of organisations utilising Garner Consulting’s expertise

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

Urine and Faeces Excretion Graph

Study Results

Case Study 2

Background

A small biotech company wished to conduct an Absolute Bioavailability study with AMS bioanalysis

Solution

Suppliers of radiochemistry, clinical and AMS bioanalysis services were identified and contracts put in place

Outcome

The company obtained Absolute Bioavailability data ie F, V and CL which enabled them to amend their formulation to improve drug exposure

Absolute Bioavailability Chart

Case Study 3

Background

The EU paediatric organisation, PRIOMEDCHILD, issued a call for proposals on microdose studies with AMS bioanalysis to obtain paediatric PK.

Solution

Garner Consulting identified partners in four countries and six centres, wrote up a research outline and then a full proposal.

Outcome

PRIOMEDCHILD approved the application and awarded a 3 year €1.2 million grant. The Project Co-ordinator is Professor Kevin Park, University of Liverpool and Garner Consulting is the Project Manager - read more here

Mass Spectrometer