Environmental risk assessment of active pharmaceutical
Client
A pharmaceutical product development company
Background
Following MHRA feedback on a previous Marketing Authorisation submission, our client required generation of a new environmental risk assessment (ERA) for a paediatric drug product.
Project goals
The first stage of an ERA is to calculate the predicted environmental concentration in surface waters (PECsw) of the drug (Phase I of EMA guidance). To search for, identify, and summarise relevant information on the likely environmental exposure to the intended marketed product and to refine the PECsw value appropriately.
Approach
Relevant data were identified on the fraction of the UK paediatric population that are likely to be administered the drug product (based on robust NHS statistics) and the maximum exposures were determined. Using this information the PECsw value was calculated and refined (according to EMA guidance) and the approach fully justified and documented in a bibra report co-authored by a partner consultancy expert in environmental assessments.
Project outcome
Bibra and its expert partner successfully completed Phase I of the ERA with a comprehensive justification for the method used in calculation of the PECsw. As the PECsw was found to be lower than the EMA ‘action limit,’ a Phase II ERA was not deemed necessary (saving the coming significant time and financial resources).
Project Team
Charles Johnson
Richard Young
Pharmaceuticals
More recent work
Info about us
Meet our team
