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The Value of Drug–Drug Interaction Risk Assessments

Posted on June 28th, 2017 by in Pharma R&D

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Should a drug candidate move on to pre-clinical and clinical trials? It’s a question that every pharmaceutical developer must face, and the earlier they can answer it, the better in terms of use of time and effort.

There are many important things to consider when looking at the potential of a new compound—efficacy, metabolism, toxicity on its own, potential return on investment, and so on. Among the most important and most challenging assessments are risk–benefit analyses, which include determining the potential for drug–drug interactions (DDIs).

Because the safety of a drug does not depend on its action alone, but also on its interaction with other drugs and their metabolites, a complex biochemical network must be assessed. Identifying adverse interactions is required by regulatory authorities, who demand that submissions include clinical DDI studies for common drugs and likely co-medications.

Beyond being required by regulatory bodies, DDI assessments of candidate compounds have considerable value to pharmaceutical developers, especially if they can be done early using dedicated in silico tools.

The benefits include:

  • Eliminating unfavorable candidates before they fail: Why put a compound through clinical trials when its adverse DDIs would result in failure or release to market with severe prescription restrictions? Early identification of failure is clearly economically desirable.
  • Informing decisions on which DDI-focused clinical trials are needed: Considerable time and effort can be saved if a pharmaceutical developer can prove that a DDI-focused clinical trial is unnecessary because there is no risk of an adverse interaction. Regulatory authorities will accept evidence from in silico assessments as proof of no or low risk.
  • Making clinical trials safer: Identifying the risk of interactions with co-medications that trial participants already take is an important aspect of planning a clinical trial. It helps to ensure that the trials are safer, as alternative, lower-risk co-medications can be found prior to first-in-human use.
  • Planning the drug’s life cycle with the right information: Common drugs, such as analgesics and anti-histamines, can be involved in adverse DDIs, as can certain dietary supplements. Knowing this information early means knowing what prescription restrictions and usage issues might crop up—and that means knowing the return on investment that can be expected.

In silico assessments of DDIs require comprehensive data on drug pharmacokinetics, metabolizing enzymes and transporters, and toxicity. Such data can be found in FDA and EMA documentation and the literature and tools now exist to quickly retrieve it and perform risk calculations for multiple drugs at once.

PharmaPendium’s new DMPK Solution is such an in silico tool. Designed to provide the answers for accurate assessments of DDI risk, it leverages data excerpted from regulatory documents and literature along with the powerful DDI Risk Calculator. Discover more about this new research solution and see its value to your drug candidate prioritization.


 

All opinions shared in this post are the author’s own.

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