Connect with us during the 4th Drug-Device Combination Products Summit

During the 4th Drug-Device Combination Products Summit (May 18-19), we shall present "From extractables to leachables - How to deal with complicated formulations" Request our presentation now.

Evolution of drug device combination products (CPs) continues to increase, driven by the need for novel medicines, greater demand for injectables, self-administration or patient-friendly means of delivering drug products. Safety evaluation and qualification of the constituent parts or materials used need to comply with the regulatory expectations in the jurisdiction of interest. A key objective during development is to evaluate the risks associated with extractables and leachables to ensure that they are mitigated and controlled.

During the 4th Drug-Device Combination Products Summit, 18th – 19th, May 2021, our expert, Stefan Heck will present "From extractables to leachables – How to deal with complicated formulations."

REQUEST PRESENTATION

Extractables and Leachables are a serious problem associated with the safety of drug device combination products, which is getting worse with increasing complexity of packaging systems and drug matrices. In this presentation, Stefan will discuss the following topics in detail:

  • Best practice study design which covers the whole product cycle from production-process to the final container closure system
  • Practical solutions for E&L including evaluations of complex material combinations and potential difficulties with formulation interference during leachables studies including possible solutions
  • Unknown extractables and leachables and how to deal with them

One of our representatives would be delighted to send you this presentation after the conference (18th – 19th, May 2021).

 

 

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