Phase 1 : Initial trials of the drug in humans. The objective of this phase is to assess dose ranges and to conduct early pharmacokinetic studies. Phase 1 trials aim to determine the mode of administration of the study drug, the safest dosage and the maximum tolerated dose. They also investigate what effect the study drug has on the body, and what potential side effects people taking the drug or treatment experience. Trials in this phase include a small number of healthy volunteers, who are exposed to the drug for a short amount of time.
Phase 2 : Evaluating pharmacodynamics. Phase 2 trials have multiple objectives, some of which includedemonstration of therapeutic efficacy, determining dosage, study of effects / circulating concentrations, evidence of factors that can modify the kinetics (concomitant medications), and determining short-term adverse events. Although Phase 2 trials have two objectives; safety; and the determination of whether the study drug is effective for the condition in question based on the dose and drug administration schedule determined in prior Phase 1 trials. These trials are carried out in a limited number of subjects suffering from the condition in question, and the duration of exposure to the drug is usually short.
Phase 3 : Studies that confirm and further the results of efficacy and safety. Phase 3 trials confirm and provide further results regarding the safety and efficacy of the drug. Adverse reactions to the study drug are observed and documented. As well, other characteristics of the drug are studied, (eg, drug interactions, factors that may affect outcomes, etc.). Phase 3 trials require a larger number of study subjects, and their duration of exposure to the study drug may be longer. If the results of a Phase 3 trial show that the study drug is better than the standard treatment, the study drug may move forward to become the new standard treatment.
Phase 4 : The objective of Phase 4 trials is to father more information about the possible benefits and risks of a study drug; that didn’t show up in earlier phase trials. Phase 4 trials are also used to: refine the knowledge of the drug; the frequency of adverse effects; evaluate the treatment strategy; and adapt the dosage for particular cases not taken into account in previous trials. These trials require a very large number of patients and they can reveal rare side effects.These studies are carried out after the marketing authorization for the study drug has been granted. Phase 4 trials typically involve patients that have been taking the study drug for a considerable amount of time under the supervision of a physician.
At our office, we are specialized in conducting Phase 2 and Phase 3 clinical studies alongside international leaders in the pharmaceutical industry. It is through these close partnerships that novel therapeutics are discovered.