RD&C has a sound track record in preparing ERAs with experience in various types of formulations (oral, parenteral, inhalation, transdermal etc.). We have successfully provided ERAs for different drug classes such as hormones, endocrine disruptors, NCE, generics, antibiotics, etc. at most efficient resource investment.

RD&C’s new approach for ERA focusses on several points:

 

  • Calculation of Fpen and PEC values: Fpen refinement based on prevalence data and evaluation of suitability of market data

 

  • Consideration and interpretation of literature data

 

  • Full in silico environmental risk assessment

 

  • Appraisal of physicochemical parameters on environmental fate

 

  • Chemical evaluation of degradation pathways and drug metabolism; evaluation of relevance for ERA

 

  • Environmental fate and purge discussions

 

  • Strong efforts to keep laboratory experiments to a minimum

 

  • Selection of most relevant assays, species and experimental set-up

 

  • Selection and close interaction with CROs

 

  • Discussion with authorities

 

  • Compilation of comprehensive regulatory compliant ERA documents

 

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