Our scientists are leveraging the latest technologies and scientific advances to discover and develop new medicines.
Conduct of clinical trials &
The clinical development process is divided into phases that help us
learn important information in a step wise fashion. Depending on the
drug and disease being studied, the process might begin with a single
dose in healthy volunteers. For other disease states such as cancer,
the studies may start with patients and allow dosing for as long as
the patient is getting benefit from the drug. There is not a single
method that can be used for all drugs and diseases. However, there are
some general steps that are important for the development of all drugs
depending on the trial participants and the aspects of the drug being
assessed. Clinical trials can take place prior to the approval of a
drug (premarket) and after the approval of a
- Phase 1 studies are the first time an investigational drug is given to humans. These studies help determine how often a drug should be given and if there are important side effects that doctors and patients need to be aware of.
- Phase 2 studies have the primary objective of exploring
the therapeutic effect and to further evaluate safety of a drug in
patients with the disease or condition intended for treatment.
- Phase 3 studies are conducted in larger groups of patients
and are conducted to confirm the safety and efficacy of a drug in
the treating the intended disease. Because Phase 3 studies are
larger, they allow investigators to find and understand less common
side effects of the drug. This is important information for doctors
and patients to know before use in the wider general population.
Phase 3b studies are either studies conducted while a drug is under
review by a regulatory authority or are studies conducted in
patients that do not fall within the proposed or approved drug
- Phase 4 postmarketing studies are conducted
after a drug is approved to gain additional information, including
the drug’s effects across various populations and side effects
associated with long-term use in the drug’s approved
Post Marketing Commitments (PMCs) and Post Marketing Requirements (PMRs) are studies and clinical trials conducted by a sponsor after the Food and Drug Administration (FDA) has approved a drug or biological product. The studies/trials are designed to generate additional information about the product’s safety, efficacy, or appropriate use. PMCs are studies or trials a sponsor has agreed with FDA to conduct; they are not required by statute or regulation. PMRs are studies or trials that sponsors are required to conduct post-approval according to statute or regulation.
AbbVie and Allergan are subject to PMCs and PMRs covering a range of
studies/trials in various stages of development. Information about
AbbVie’s and Allergan's post marketing commitments and post marketing
requirements is believed to be correct at the time that the
information is posted, and is subject to change as progress is made in
fulfilling the commitments.