Accelerated Clinical Development

Pharmaron’s clients are using AMS to improve the efficiency of R&D through a combination of not only reduced development time, but also in many cases, reduced expense.

• Analytical method development and validation is off the critical path as the ultimate analyte for AMS is ¹⁴C and lower limits of quantitation (LLOQ) can be determined mathematically
• AMS methods are independent of matrix effects and chemical structure and are not affected by molecules that ionize poorly or lack chromophores
• Our intelligent non-clinical and clinical study designs are often shorter in duration and require less resource
• AMS generates rich data sets comprising all drug–derived material (total radioactivity), specific analytes (parent compounds and metabolites of interest) and fully quantitative metabolite profiles
• The use of ¹⁴C microtracers negates the need for full GMP ¹⁴C-API in human studies and most clinics do not require dosimetry data
• All GCP AMS-enabled clinical studies are fully acceptable and submissible to regulatory authorities (FDA, EMA, TSA, etc)

Clinical AME