RenaSci

Abuse Liability Testing Collaboration (ALTeC)Abuse Liability Testing Collaboration

 

Over recent years there has been an increasingly conservative approach to new drug approval in the USA and Europe with a much greater focus on safety. The regulatory bodies in each territory now demand abuse liability testing on all CNS-acting drugs and also a continual process of safety and abuse-monitoring after the drug has been approved.  A further complication in this field has been the different requirements for abuse liability testing and post-approval safety monitoring between the USA and Europe.

ALTeC was established in 2009 by RenaSci and Pinney Associates Inc (Bethesda/Pittsburgh) to provide the biotech and pharmaceutical industry with a solution to the changing regulatory and marketing environment for centrally-acting drugs. We do this by bringing together world experts in drug regulatory affairs to provide a unique “one-stop shop” integrated service for abuse liability testing in animals and man. This provision extends from the early preclinical stages of a drugs life through to clinical drug development and post-marketing surveillance.

Our American partners are science and public health policy consultants with unique experience in drugs that act on the CNS whereas we offer consultancy at all levels of the drug development process and pre-clinical abuse liability testing. Together, we have a thorough understanding of the different requirements for abuse liability testing and post-marketing surveillance in both the USA and Europe. We have the specialist knowledge required to design, perform and report preclinical and clinical drug abuse liability studies to the most exacting regulatory standards and the expertise and experience to provide advocate support at regulatory hearings. ALTeC facilitates drug development by working closely with your representatives and the regulatory authorities to perform an appropriate and efficient abuse liability evaluation and optimum Controlled Drug labelling.

 

Please contact us for further information about ALTeC.

 

Recommended reading


Silvia Calderon, Alessandra Giarola and David Heal. Chapter 10. Regulatory framework and guidance to the evaluation of the abuse liability of drugs in the United States and Europe. In: Nonclinical Assessment of Abuse Potential for New Pharmaceuticals, 1st Edition. Carrie G Markgraf, Thomas J Hudzik and David J  Compton (Eds). Academic Press, Elsevier, pp 245-268, 2015.