Clinical Pharmacology and Its Role in Pharmaceutical Development

The new drug development process is carried out through a sequence of developmental and evaluative steps. The European and US regulatory authorities have established substantial regulatory guidance regarding drug development and the regulatory approval of Clinical Trial Application (CTA), Investigational New Drug Application, and New Drug Application (NDA) submissions. The process includes preclinical research and development, clinical development phases, and NDA review by the US Food and Drug Administration or CTA review by the European Medicines Agency. In the United States, for drugs that are shown to be effective and that can be administered with acceptable toxicity, the process results in NDA approval and marketing of the drug. In Europe, the drug evaluation is carried out by the Committee for Medicinal Products for Human Use. If the quality, safety, and efficacy of the medicinal product are sufficiently acceptable, a recommendation is sent to the European Commission to be transformed into a marketing authorization valid for the whole of the European Union. The science of clinical pharmacology provides the backbone for the methodologies developed and implemented across the pharmaceutical industry to improve the odds of success and address the challenges of “getting the dose right.” Clinical pharmacologists contribute their ability to integrate basic and clinical biomedical sciences and bring detailed expertise on the mechanism of action of drugs, dose–response relationships, adverse effects, drug metabolism, pharmacokinetics, and pharmacogenetics, coupled with knowledge of clinical trial optimization for drug development and the therapeutic applications of drugs in modern medical practice.