Clinical Pharmacology Studies Impact the Product Label
Clinical pharmacology studies provide critical information for the drug product label in terms of understanding how age, gender, disease and other drugs affect drug disposition and eventually how the drug is to be prescribed by the practicing physician. Celerion has over 40 years of experience in conducting product labeling studies that have supported many drug marketing applications. Based on our considerable knowledge in this area, Celerion is able to proactively create efficient and cost-effective packages of product labeling studies, thereby allowing the same team of scientists to apply knowledge of the drug across all studies when performing the conduct and analysis.
Product Labeling Package Experience
Celerion understands the considerations of managing programs of product labeling studies of varying size and timing. All the appropriate product labeling clinical pharmacology studies need to be completed within the 1 to 5 year timeframe it takes to conduct the pivotal studies. Often from a resource management perspective drug developers wait until the pivotal trials are underway before focusing attention on the product labeling program. These programs involve the conduct of several studies in parallel to obtain the required data for the marketing submission. Celerion has the clinic capacity to manage the execution of several studies simultaneously to ensure that your submission timelines are not compromised. We overcome the key challenge of efficiently collecting these data while keeping to these tight timelines.
Efficiency Comes From Experience and Scale
While there is no one single approach, careful consideration of some specific areas will benefit your overall development. Below are considerations that help efficiently apply knowledge of the drug across all studies resulting in saving time, effort and cost. Regulators are allowing more creative approaches to product labeling study design. Celerion can advise you on these novel designs. For consistency of data, Celerion clinics and bioanalytical laboratories in the US and Europe all work to the same SOPs and common data capture and analysis systems. Additionally, working with Celerion for your early clinical development and other clinical pharmacology studies allows the same team of scientists to apply their knowledge of the drug across all studies when performing the conduct and analysis.
Depending on the drug and the quality of the non-clinical testing performed, there may be existing data to rationalize not doing one or more product labeling studies.
Consider all the product labeling studies as a package of work rather than separate studies as this provides an opportunity to assemble the same team of scientists to perform conduct and analysis.
Celerion leverages innovative methods such as low dose radiolabeled drug (microdose) combined with accelerator mass spectrometry as a new way to study ADME and absolute bioavailability in healthy participants and patients.
Leveraging highly automated digital processing saves weeks of time and cost over traditional manual adjudication methods, while still ensuring the required precision needed for successful conduct of a TQT cardiac safety study.
Using robust PK/PD modeling approaches that provide in silico predictions of the impact of other drugs, food and disease states on a drug’s disposition are reliable approaches to supplement regulatory submissions of product labeling for marketing approval.