What is Clinical Pharmacology?

Clinical Pharmacology (CP) promotes the rational use of medications in humans by studying their restorative effect to amplify the drugs effect and reduce the side effects. CP bridges the gap between science and the practice of medicine through innovative research, development and regulation of medications.

CP assessments are essential to determining the right dose, at the right time, in the right patient population. CP integrates other life sciences such as biology, biochemistry, drug metabolism, pharmacokinetics (PK), pharmacodynamics (PD), drug safety, drug formulation, drug interactions, and patient demographics. CP provides an integrated drug development strategy by applying learning and confirming across the entire drug development program. CP provides a roadmap that  guides the rest of the drug development program to successful regulatory approval.

State-of-the-Art Services

We can guide your program from candidate selection through NDA or BLA and even through post-marketing activities. We can help inform decisions from FIH to Phase 1a/b, Phase 2a/b POM, POC, and designing pivotal Phase 3 study. In addition, we support clinical pharmacology in drug development with services that include: 

• Compartmental PK analysis
• Noncompartmental Analysis (NCA), including bioequivalence analysis
• Toxicokinetic Analysis
• Generating submission-Ready Study Reports