Modelling candidate drug exposure in humans and its relationship to safety and efficacy to:
Recommend drug delivery system designs that will give the required exposure.
Recommend in vitro formulation performance characteristics necessary to ensure good performance in patients.
Dosing regimens to achieve optimal safety and efficacy in humans.
Understanding potential drug drug interactions ensures the safe use of candidate drugs in early clinical development through identification of appropriate restrictions in early clinical studies (i.e what other drugs the candidate drug can be co-dosed with).
For drugs in the later stages of development, we can provide expert guidance on:
How to bridge the in vivo performance of early phase and later phase formulations, including pivotal clinical and commercial products(bioequivalence).
Clinical pharmacology studies required to support labelling requirements (such as drug-drug interaction studies) to enable marketing authorisation.This can include study design, data analysis and interpretation.
Understanding Drug-Drug Interactions
We can also develop appropriate clinically relevant dissolutions tests, which can be used as surrogates for performance in humans, and which will form the basis of the (quality) control strategies for new products.
Clinically relevant dissolution tests are becoming increasingly important because:
They ensure, that during pivotal studies, the drug product will provide the necessary exposure in patients
Provide reassurance to regulators facilitating greater regulatory flexibility and a more robust supply chain.
Clinically Relevant Dissolutions Tests
Modelling Drug Exposure to Enable Product Design
Linking Patients Needs to Product Performance
Clinical Pharmacology and Biopharmaceutics
Seda Pharmaceutical Development Services’ Clinical Pharmacology and Biopharmaceutics capability is aimed at supporting the optimal design of drug product and optimal clinical use of the drugs. This service includes modeling drug exposure to enable product design, the development of clinically relevant dissolution tests, formulation bridging studies (bioequivalence) and understanding drug drug interactions.