Aptuit | Drug abuse liability

Drug abuse liability

Proactive approaches to interrogate a complex matter

We work closely with our customers to deliver a fully flexible package of abuse liability services that can be tailored to your needs in accordance to regulatory requirements, as strategies are best designed on a case-by-case basis.

Aptuit | Drug abuse liability

Expert, fully-integrated and supported by an array of experience and knowledge, our abuse liability solutions optimize strategy design to deliver the most complete, yet lean, package to maximise success for our customers. We are aware that an appropriate Abuse Liability Strategy for an asset can mean the difference between failure and success.

We work with you to facilitate early discussion between research teams and key stakeholders to ensure all factors are addressed appropriately.

The preliminary characterisation of the compound, including structure, mechanism of action, physico-chemical properties, pharmacokinetic, pre-clinical and clinical safety data is critical in order to define subsequent scientific and regulatory needs for the product. We will provide the oversight of such data to deliver the most effective abuse liability strategy.

Our abuse liability services include:

  • Consulting on abuse liability strategy and 8-factor analysis
  • Evaluation of chemical similarity
  • In vitro studies: binding to specific targets and functional assays
  • In vivo /ex vivo binding: rate of brain entry/onset
  • Broad range of behavioural studies: drug discrimination; self-administration; withdrawal
  • All of the behavioural studies can be performed with DMPK assessment to establish PK/PD relationship
  • All abuse liability studies can be performed in compliance with the US Food and Drug Administration Good Laboratory Practice for Nonclinical Laboratory Studies