2/8/2018
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`Drug Approvals - From Invention to Market...12 Years!
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`home / medications center / medications a-z list / drug approvals - from invention to market article
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`In the United States, it takes an average of 12 years for an experimental drug to travel from
`the laboratory to your medicine cabinet. That is, if it makes it.
`
`Only 5 in 5,000 drugs that enter preclinical testing progress to human testing. One of these 5
`drugs that are tested in people is approved. The chance for a new drug to actually make it to
`market is thus only 1 in 5,000. Not very good odds.
`
`The process of drug approval is controlled in most countries by a governmental regulatory
`agency. In the U.S., the Food and Drug Administration (FDA) governs this process. The FDA
`requires the following sequence of events before approving a drug.
`
`Preclinical Testing: A pharmaceutical company conducts certain studies before the
`future drug is ever given to a human being. Laboratory and animal studies must be
`done to demonstrate the biological activity of the drug against the targeted
`disease. The drug must also be evaluated for safety. These tests take on the
`average 3 1/2 years.
`
`Investigational New Drug Application (IND): The pharmaceutical company (cid:161)les an
`IND with the FDA to begin testing the drug in people. The IND becomes effective if
`the FDA does not disapprove it within 30 days. The IND must include the following
`information: the results of previous experiments; how, where and by whom the new
`studies will be conducted; the chemical structure of the compound; how it is
`thought to work in the body; any toxic effects found in the animal studies; and how
`the compound is manufactured. The IND must also be reviewed and approved by
`the Institutional Review Board where the studies will be conducted.
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`2/8/2018
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`Drug Approvals - From Invention to Market...12 Years!
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`Phase I Clinical Trials: Phase I studies are usually the (cid:161)rst tests of a drug under
`development in healthy volunteers. These studies involve about 20 to 80
`volunteers. The tests determine a drug's safety pro(cid:161)le, including the safe dosage
`range, plus how the drug is absorbed, distributed, metabolized and excreted, and
`the duration of its action. Phase I trials take on the average 1 year.
`
`Phase II Clinical Trials: These are slightly larger studies that are done in patients
`with the disease for which the drug is intended. This phase is usually designed to
`identify what are the minimum and maximum dosages. The trials generally involve
`100 to 300 volunteer patients and are controlled in design. They are done to assess
`the drug's effectiveness. Phase II typically takes about 2 years.
`
`Phase III Clinical Trials: These are the de(cid:161)nitive, large randomized trials that are
`submitted to the FDA in order to obtain approval of a drug. This phase examines
`the effectiveness as well as the safety (adverse events) of the new drug. Phase III
`trials usually involve 1,000 to 3,000 patients in clinics and hospitals. Patients are
`usually asked a list of possible side effects, often derived from what was observed
`in phase II studies. Patients are also free to report any other side effects that occur
`while they are on the new drug or the placebo (the "sugar pill" that is given to a
`percentage of patients in a trial study). Phase III takes on the average 3 years.
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`New Drug Application (NDA): Following the Phase III Clinical Trials, the drug
`manufacturer analyzes all the data from the studies and (cid:161)les an NDA with the FDA
`(provided the data appear to demonstrate the safety and effectiveness of the drug).
`The NDA contains all of the data gathered to date about the drug. (An NDA typically
`consists of at least 100,000 pages.) The average NDA review time for new drugs
`approved in 1992 was close to 30 months (2 1/2 years).
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`2/8/2018
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`Drug Approvals - From Invention to Market...12 Years!
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`Phase IV Studies: Phase IV is any organized collection of data from patients who
`are taking a drug that has already received approval from the FDA. In Phase IV
`studies, patients may check boxes on a list (as in phase III studies) or they may just
`report other symptoms. Phase IV studies are commonly called "post-marketing
`studies."
`
`Although there are other routes that can expedite the process (referred to as fast-tracking),
`this is the usual journey for a drug from invention to market in the U.S.
`
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`2/8/2018
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`Drug Approvals - From Invention to Market...12 Years!
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`Drug Approvals - From Inventio…
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`https://www.medicinenet.com/script/main/art.asp?articlekey=9877
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`Abraxis EX2076
`Cipla Ltd. v. Abraxis Bioscience, LLC
`IPR2018-00162; IPR2018-00163; IPR2018-00164
`
`