Seda Pharmaceutical Development Services’ Clinical Pharmacology expertise is unique in that it is fully integrated with our Pharmaceutical Development and Biopharmaceutics capability and is aimed at supporting drug product design alongside optimal use in the clinic. Seda’s Clinical Pharmacologists apply their deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), and pharmacology to input to appropriate clinical trial design, contributing to aspects such as start dose, dose escalations, PK sampling schedule, food effect and drug-drug interactions. This service links seamlessly with Biopharmaceutics modelling of drug exposure to enable product design, the development of clinically relevant dissolution tests, food effect and formulation bridging studies (bioequivalence).
Support we can provide includes:
- First in Patient Clinical Study Design (Clinical Pharmacology perspectives)
- Controlling risk to subjects
- DDI: Understanding potential drug interactions ensures the safe use of candidate drugs in early clinical development through identification of appropriate restrictions (i.e. what other drugs the candidate drug can be co-dosed with).
- Dose: Supporting starting dose selection and PK interpretation during dose escalation and cohort expansion
- Ensuring the study design will meet the objectives
- Exclusion and Inclusion Criteria: focused on patient characteristics that may affect PK exposure
- PK-PD understanding to support choice of go forward dose
- Technical writing of appropriate sections of Clinical Trial Application (CTA)
- Controlling risk to subjects
- 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, and design dosing regimens to achieve optimal safety and efficacy in humans.
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. - Technical authoring of NDA/MAA clinical summary sections “Biopharmaceutics and Associated
Analytical Methods” and “Clinical Pharmacology Studies” and support for labelling. - Clinically relevant dissolution tests. They ensure, that during pivotal studies, the drug product will
provide the necessary exposure in patients and provide reassurance to regulators facilitating greater
regulatory flexibility and a more robust supply chain
