Clinical Pharmacology Integrated Drug Development
Clinical pharmacology integrates numerous topics that are essential to determining a drug’s dose, designing studies, and forming an overall drug development strategy. These topics include biology, biochemistry, ADME (absorption, metabolism, distribution, and excretion), pharmacokinetics (PK), pharmacodynamics (PD), pharmacometrics (modeling and simulation), pharmacogenomics, time course of disease, human toxicology, formulation and route of administration impact, drug interactions, and specific population considerations, etc.
Our specialized focus in clinical pharmacology provides a streamlined and integrated drug development strategy by learning and confirming the science and value of the drug for patients across the entire drug development program. If done properly, clinical pharmacology is a roadmap that efficiently guides the rest of the drug development program to successful regulatory approval.
Allucent’s team of clinical pharmacology experts can guide your program from candidate selection through critical studies, driving decisions in real-time, for first-in-human (FIH), Phase 0 proof of mechanism/principle, Phase 1b/2a proof of concept, Phase 2b dose-ranging and adaptive designs, simulations for Phase 3 design options benchmarked to the standard of care, innovative regulatory strategies, quality submissions, and more with our integrated approach.