Phase I

Phase I clinical trials focus on the safety, rather than the effectiveness, of a new compound. During this stage very low doses of the compound are administered to a small group of healthy volunteers under the close supervision of a doctor. Very gradually, doses are increased while doctors study the participants carefully to determine how their bodies react to the compound, whether the compound is sufficiently absorbed and persists in the bloodstream, and which dosage levels are safe.

Phase II

The second stage of clinical testing focuses on the compound's effectiveness against the illness it is designed to treat. During Phase II, researchers also seek to determine the most effective dosages for the new medicine and the most appropriate method of delivering the drug (for example, oral tablets, extended release capsules, or injections). This stage involves testing in about 100 to 300 patients who are in need of treatment and who volunteer for the tests. The patients for Phase II studies are drawn from research centers and hospitals across the country and around the world. As is true for all studies in all phases of drug development, strict guidelines of informed consent are observed so that the risks and potential benefits are clearly explained to the patients.

Phase III

In the final stage of human clinical trials, researchers aim to confirm the results of earlier tests in a large, worldwide patient population. This phase can involve 3,000 to 10,000 patients in hundreds of hospitals and medical centers. The large number of patients involved also allows researchers to establish a broad database of information about the safety and efficacy of the drug candidate to satisfy government regulatory requirements in the many countries where it will be sold. The large group of geographically diverse participants also enables researchers to identify those rare adverse effects that may affect only a few patients in a thousand.

Registration

The filing of a New Drug Application with the US Food and Drug Administration (FDA) or a Market Authorization Application with the European Agency for the Evaluation of Medicinal Products (EMEA) seeking to demonstrate the safety and efficacy of our medicines and approval to market them.

Recent Approvals

Medicines that have recently been approved for marketing in the US or Europe and are either currently marketed and available to patients or about to be launched and made available in the near future.