What is Clinical Pharmacology?
Clinical pharmacology is the application of pharmacological principles in clinical studies to understand the interaction between drugs and humans, and to promote the safe, effective and economic use of medicines. It is the study of drug exposure, drug metabolism, drug’s effect on human (e.g. biomarker changes, efficacy and toxicity) as well as factors that contribute to the variability in responses in human. Ultimately, this understanding leads to proper dose and dosing regimen selection for different populations.
When to use Clinical Pharmacology Support
Clinical pharmacology is a critical component of clinical development, and clinical pharmacologists are often an integral member of project/clinical development teams. Clinical pharmacology and modeling and simulation groups work closely together to perform the proposed analyses. Some example contributions are listed below:
- Clinical development strategy
- Clinical pharmacology strategy
- Clinical trial design
- Strategy for translating preclinical data to inform FIH starting dose selection and human efficacious dose prediction
- Dose and dosing regimen selection strategy
- PK and PD sampling schedule, balancing scientific needs and practical considerations
- PK and PD analysis plan and data visualization
- Non-compartmental PK analysis
- Regulatory support
Non-compartmental analysis (NCA) is a quick, straightforward way to characterize the pharmacokinetic properties of new drugs. They provide useful information that can be used to inform drug development decisions, particularly when those decisions need to be made on very short timelines, like during dose escalation in a first-in-human (FIH) trial. PK parameters derived from NCA are easy to understand and are generally reported in clinical study reports and in the label for drugs that have achieved regulatory approval. They are also conducted for preclinical PK studies, and provide the basis for calculating exposure margins used to support FIH dose selection.
Clinical Pharmacology Strategy
There are many factors to consider when developing a clinical pharmacology plan. Examples of strategic contributions include:
- Do we need to run a dedicated hepatic or renal impairment study?
- What is the potential for drug-drug interaction (DDI) and how should we manage potential interactions?
- Can we use population modeling to address clinical pharmacology questions instead of running a dedicated study?
- What studies should we run to ensure future studies have more inclusive inclusion/exclusion criteria and maximize potential enrollment?
- How can we justify switching from weight based dosing to flat dosing?
We can provide writing for clinical pharmacology related sections of the regulatory documents such as dose rationale in study protocol and regulatory briefing book.
What scientific questions are you trying to answer? We'll put you in touch with the right person on our team.