Valeant Pharmaceuticals is a specialty pharmaceutical organization that conducts clinical studies to test
investigational drugs for potential approval and use in patients to treat specific diseases.
These studies are performed to support the approval of a drug by regulatory agencies. Typically, these
studies are conducted in specialized clinical trial units by investigators who enroll and monitor patients
to determine the safety and efficacy of a drug and to better understand its potential benefit to patients.
Although Valeant is the sponsor of these studies, the success of a clinical trial or compound depends on the
supportive and collaborative efforts of Valeant, the investigator, the study coordinator, and the patient.
Doing what is right for the patient is Valeant's first priority.
Phase 1 studies are the first studies of a new drug in humans, typically in healthy volunteers. These
studies are usually conducted in highly specialized Phase 1 centers where subjects are thoroughly evaluated
for study participation and closely monitored throughout the entire dosing interval after they are enrolled
in the study. Phase 1 studies are designed to determine the absorption, distribution, metabolism and
excretion of the drug, and to provide an early or preliminary assessment of the drug safety, pharmacokinetic
(PK) profile, and identification of possible drug-drug interactions and food interactions. Phase 1 studies
also typically include PK studies in study volunteers with renal and hepatic impairment.
Phase 2 studies are conducted in patients with the targeted disease. The purpose of Phase 2 studies is to
demonstrate the pharmacodynamics of the new drug and to assess its short-term safety in patients. Phase 2
studies also explore possible effective dose ranges and regimens, and, if feasible, clarify the
dose-response relationship to help guide the design of large therapeutic Phase 3 trials.
Phase 2a trials are open-label or double-blind and conducted in a limited number of subjects. Later-stage
studies, Phase 2b trials, are conducted in a greater number of patients. Phase 2 studies are typically
placebo-controlled, comparative design trials.
If the Phase 2 study results are positive, Phase 3 studies are usually implemented. Phase 3 studies are
designed to demonstrate sufficient proof of efficacy and adequate safety of the new drug in a large number
of patients with the targeted disease or condition.
Phase 3 studies explore the therapeutic value and determine the short-term and long-term safety and efficacy
balance. The profile of adverse drug experiences and the special features of the new drug are rigorously
explored. Phase 3 studies are typically randomized and double-blind, however other designs may be used (e.g.
long-term safety studies). Later-stage Phase 3 studies, Phase 3b studies, are conducted after the drug
application is submitted for approval to the regulatory agency, but prior to the new drug's approval. In
Phase 3b studies, the new drug may be compared with others already established as effective or such studies
are designed to complete or augment earlier trials.
After a drug is approved for marketing, Phase 4 trials may be initiated to further evaluate the effect of
the drug for the approved use, determine if there are additional therapeutic uses for the drug, and to
gather additional safety information. Regulatory agencies sometimes require Phase 4 studies to address a
specific concern or to gather and evaluate additional data following more widespread use of the drug.
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