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How can I make sure my data meets regulatory expectations?

Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to know exactly how to plan assays to get acceptable data—our scientists have made a career of piecing it together and we work with clients every day to make sure your data is IND-ready.

Preclinical study planning within a drug’s development strategy can be highly variable depending on the chemical properties of the molecule, indication, the company’s size and funding, internal capabilities, and other factors. Additionally, as the pharmacokinetic/pharmacodynamic (PK/PD) profile of a molecule is elucidated with each study, necessary next steps in investigation can be difficult to see with certainty. Regulatory authorities, e.g., the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA), will offer prescriptive guidance documents describing the data endpoints and calculations required to demonstrate safety considerations (for drug-drug interaction studies), but often without specific direction for study design.

Some nonclinical studies have been around for years and now could be considered stock-standard for inclusion in applications for regulatory approval of prospective drug compounds. For example, enzyme inhibition and metabolite characterization have long been included in the submission of an Investigational New Drug (IND) application to the FDA, Clinical Trial Authorisation (CTA) to the EMA, and equivalent applications to other regulatory bodies worldwide. However, the methods by which drug developers can best provide these data have evolved as science advances and emphasis on metabolites and DDI potential grows, and drug developers must keep up with new technology and guidance updates in order to meet expectations1.

Legacy data can also present an opportunity for missteps in development. For example, studies conducted a few years ago, which indicated insignificant levels of enzyme inhibition, may need to be repeated as more rigorous methodology has been implemented and concentration requirements have changed.

Regulatory authorities may request nonclinical follow-up studies to explain unexpected results in clinical trials or as a condition of approval for an IND/CTA application. Careful design and planning of these supporting studies are critical and intimate knowledge of drug metabolism and pharmacokinetics (DMPK) can mean the difference between success and failure of a compound.

We can help you make these choices. DDI and ADME (absorption, distribution, metabolism, and excretion) represent only a small fraction of nonclinical studies in a drug’s development, but nuances in study planning and regulatory standards make the terrain of DMPK complex and sometimes difficult to navigate. Our team of experts read, manage, interpret, and perform DMPK assays all day every day to build a wealth of knowledge and experience in drug metabolism so you don’t have to.

We maintain a consultative approach in all aspects of service to our clients—in planning and executing contracted studies, helping you select appropriate test systems for your in-house assays, or offering expert consultation for your upcoming IND application. For over 25 years, our scientists have developed protocols, perfected techniques, patented studies and test systems, and fostered scientific and regulatory scholarship in order to provide our clients with confidence that their drug metabolism and DDI data are dependable, defendable, and additive to their molecules’ journey to the clinic.


  1.  Schadt, Simone, et al. “A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the ‘Metabolites in Safety Testing’ Regulatory Guidance.” Drug Metabolism and Disposition, vol. 46, no. 6, 2018, pp. 865–878., doi:10.1124/dmd.117.079848.

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